Biotech

Coave Signs an Exclusive License Agreement with Théa to Co-Development and Commercialize CTx-PDE6b for PDE6b Associated Retinitis Pigmentosa in EU

Shots: Coave to receive $11.7M up front & equity investment, ~ $76.5M as clinical development, regulatory & commercial milestones along with royalties on net sales of the product. Both companies will co-develop Coave’s CTx-PDE6b & share the development costs Théa obtains an exclusive license to commercialize the therapy in the EU, Ukraine, Turkey, Russia, and …

Coave Signs an Exclusive License Agreement with Théa to Co-Development and Commercialize CTx-PDE6b for PDE6b Associated Retinitis Pigmentosa in EU Read More »

Clarus Signs an Exclusive WW License Agreement with McGill University to Develop and Commercialize its Technology for Rare Conditions Due to Coenzyme-Q10 Deficiencies

Shots: McGill to receive $350,000 up front, $10.5M as development and regulatory milestone & is also eligible for ~$30M as a commercial milestone. Clarus will develop and commercialize McGill’s technology targeted the conditions associated with CoQ10 deficiencies The collaboration will accelerate the development of potential treatments for rare, endocrine, metabolic, and neurological conditions associated with …

Clarus Signs an Exclusive WW License Agreement with McGill University to Develop and Commercialize its Technology for Rare Conditions Due to Coenzyme-Q10 Deficiencies Read More »

AbCellera Acquires TetraGenetics to Enhance its Capabilities for Developing Antibodies

Shots: AbCellera acquires TetraGenetics in an all-cash transaction that includes up front, milestones based on the achievement of technical milestones related to the development of therapeutics The acquisition will combine TetraGenetics’ capabilities with AbCellera’s technology to provides an optimized protein source for AbCellera’s Abs discovery across a range of therapeutic areas. The technology has the …

AbCellera Acquires TetraGenetics to Enhance its Capabilities for Developing Antibodies Read More »

ObsEva files uterine fibroid drug in US, chasing AbbVie, Myovant

Swiss biopharma company ObsEva has filed its oral GnRH antagonist linzagolix for the treatment of uterine fibroids in the US, hoping to expand the number of women eligible for this type of therapy. If approved, linzagolix will be the only drug in the class with a dosing regimen intended for women with uterine fibroids who …

ObsEva files uterine fibroid drug in US, chasing AbbVie, Myovant Read More »

Lightstone Ventures Raises $375M Fund to Invest in Early Stage Biotech and Medtech Companies

What You Should Know: – Lightstone Ventures today announced the closing of Lightstone Ventures III with $375M in capital commitments, to invest in early-stage companies developing high-impact therapeutics and technologies. – The new fund was oversubscribed, exceeding the firm’s targeted raise, and included strong support from both new and existing limited partners. With the closing …

Lightstone Ventures Raises $375M Fund to Invest in Early Stage Biotech and Medtech Companies Read More »

Rome Therapeutics raises $77m for junk DNA-targeting drugs

Startup Rome Therapeutics has raised $77 million in second-round financing to help mine sequences of DNA – which were dismissed for years as ‘junk’ – for hidden treasure. The Cambridge, Massachusetts biotech is focusing specifically on the 60% of DNA sequences that repeat themselves hundreds or thousands of times in the genome, known as the …

Rome Therapeutics raises $77m for junk DNA-targeting drugs Read More »

ONO and BMS Report Submission of sBLA for Opdivo (nivolumab) + Yervoy (ipilimumab) as 1L Treatment of Unresectable Advanced or Recurrent ESCC in Japan

Shots: The application is based on P-III CheckMate -648 study evaluating Opdivo (3mg/kg, q2w, IV) + Yervoy (1mg/kg, q6w up to 24mos.) or Opdivo + CT vs CT alone in patients with unresectable advanced or recurrent ESCC The results demonstrated an improvement in OS at pre-specified interim analysis in patients with tumor cell PD-L1 expression …

ONO and BMS Report Submission of sBLA for Opdivo (nivolumab) + Yervoy (ipilimumab) as 1L Treatment of Unresectable Advanced or Recurrent ESCC in Japan Read More »

Everest Signs a License Agreement with Providence to Advance mRNA Vaccines

Shots: Providence to receive $100M up front for Providence’s PTX-COVID19-B, mRNA technology & other products, ~$300M upon achievement of milestones, $100M in profit-sharing along with royalties in Greater China & Singapore. Providence is also eligible to receive royalties based on vaccine sales in Everest Territories Everest gains rights to Providence’s PTX-COVID19-B in Greater China, Asia, …

Everest Signs a License Agreement with Providence to Advance mRNA Vaccines Read More »

France’s biotech ecosystem is primed for growth – it’s time to feed it

After some years of stagnant funding and growth France is now at an inflection point for health care innovation, says Jeito Capital’s Dr Rafaèle Tordjman. Prior to the pandemic, our homegrown entrepreneurs felt too often they had to go abroad to the United States to get the funding they needed, government support for clinical trials …

France’s biotech ecosystem is primed for growth – it’s time to feed it Read More »

Boehringer Ingelheim Signs a Research Agreement with Twist to Discover Therapeutic Antibodies Against Multiple Targets

Shots: Twist to receive an up front for each program and $710M in clinical, regulatory, and commercial milestones for the multiple target discovery programs Boehringer Ingelheim obtains global exclusive rights to develop and commercialize any therapeutic Ab discovered under the collaboration The collaboration will utilize Twist’s Ab libraries that derived from human sequences to discover …

Boehringer Ingelheim Signs a Research Agreement with Twist to Discover Therapeutic Antibodies Against Multiple Targets Read More »

Eli Lilly Signs a License and Research Agreement with ProQR to Develop & Commercialize RNA Therapeutic for the Treatment of Liver and Nervous System Disorders

Shots: ProQR to receive $20M up front, $30M as an equity investment & is also eligible to receive ~$1.25B as development, regulatory, and commercialization milestones along with royalties on product sales The companies collaborated to develop editing oligonucleotides for five targets by using ProQR’s Axiomer RNA editing platform ProQR’s Axiomer platform technology enables the editing …

Eli Lilly Signs a License and Research Agreement with ProQR to Develop & Commercialize RNA Therapeutic for the Treatment of Liver and Nervous System Disorders Read More »

Biotech Insight podcast: Overcoming planning challenges in oncology

The first episode of Kantar Health’s new Biotech Insight podcast takes aim at the planning and forecasting challenges that biotechnology companies face, with a particular focus on oncology. Joining Dominic Tyer for this instalment of Biotech Insight are Prithu Somani, senior manager of forecasting and business analytics at Genmab, and Kantar Health’s vice president of …

Biotech Insight podcast: Overcoming planning challenges in oncology Read More »

16th Park Annual by Sahlgrenska Science Park

Nordic Health Innovation: From realisation to business A virtual life science event with thought-provoking presentations, unexpected angles, future trends and pioneering ideas. The Nordic region is scoring high on international innovation rankings year after year. But is there a Nordic way of creating innovation? And what is required to take ideas from the Eureka moment …

16th Park Annual by Sahlgrenska Science Park Read More »

Genentech Signs a License Agreement with Adaptimmune to Develop and Commercialize Cancer-Targeted Allogeneic T-cell Therapies

Shots: Adaptimmune to receive $150M up front, $150M as additional payments over 5yrs., $3B+ as research, development, regulatory & commercial milestones along with royalties across multiple programs Adaptimmune can opt for 50-50 US profit/cost-share for off-the-shelf products. If it elects to opt-in, Adaptimmune will share 50% of profits & losses from US sales & receive …

Genentech Signs a License Agreement with Adaptimmune to Develop and Commercialize Cancer-Targeted Allogeneic T-cell Therapies Read More »

NeuExcell Signs a Research Agreement with Spark to Develop a Novel Gene Therapy for Huntington’s Disease

Shots: NeuExcell is eligible to receive $190M up front, license fees, R&D, and sales milestones along with royalties Spark gets the option to license the global exclusive rights of NeuExcell’s HD program & will receive access to NeuExcell’s neuro-regenerative gene therapy platform & capabilities. NeuExcell is developing AAVs based neuroregenerative gene therapy to regenerate functional …

NeuExcell Signs a Research Agreement with Spark to Develop a Novel Gene Therapy for Huntington’s Disease Read More »

BMS Exercised Its Option to License Evotec’s EVT8683 for the Treatment of Neurodegenerative Disease

Shots: Evotec receives $20M as an option fee & is eligible to receive ~$250M as milestones along with royalties. BMS will be responsible for further development & commercialization of a product BMS has exercised its option to license Evotec’s EVT8683 after 4.5yrs. of collaboration. Evotec’s iPSC platform allows screening of human iPSC-based disease models at …

BMS Exercised Its Option to License Evotec’s EVT8683 for the Treatment of Neurodegenerative Disease Read More »

Novartis Signs an Agreement with NHS to Commercialize Leqvio (inclisiran) for the Treatment of Cardiovascular Disease

Shots: The agreement follows the NICE recommendation to deliver Leqvio via a population health management approach for high-risk cardiovascular patients across England The NICE recommendation was based on Novartis’s ORION clinical research program including P- III trials ORION-9/10/11 evaluating the safety, efficacy, and tolerability of inclisiran in 3,600 patients with CVD which showed that the …

Novartis Signs an Agreement with NHS to Commercialize Leqvio (inclisiran) for the Treatment of Cardiovascular Disease Read More »

Fresenius Medical Invests Additional $25M in Biotech Platform Humacyte

What You Should Know:  Fresenius Medical Care (FMC) today announced its plans to invest an additional $25 million in clinical-stage biotechnology platform company Humacyte following the extension of its collaboration in June. Fresenius Medical Care acquired a stake in Humacyte in 2018 for $150M as part of a strategic partnership. Following the merger of Humacyte with a special …

Fresenius Medical Invests Additional $25M in Biotech Platform Humacyte Read More »

SpringWorks Collaborates with Dana-Farber to Evaluate Nirogacestat in Multiple Myeloma

Shots: SpringWorks and Dana-Farber collaborated to evaluate nirogacestat with anti-B-cell maturation antigen (BCMA) agents in multiple preclinical multiple myeloma models SpringWorks will fund the work and will retain an option to exclusively license any new IP emerging from the research collaboration The collaboration will utilize preclinical in vivo models from the Mitsiades Lab to simulate …

SpringWorks Collaborates with Dana-Farber to Evaluate Nirogacestat in Multiple Myeloma Read More »

BeiGene Signs a Clinical Trial Agreement with ImmixBio to Evaluate IMX-110 + Tislelizumab in Solid Tumors

Shots: ImmixBio to assess the safety, tolerability, and efficacy of IMX-110 in combination with tislelizumab in a P-I/IIa trial in patients with advanced solid tumors The novel approach of combining ImmixBio’s tissue specific therapeutics (TSTx) with immunotherapies could expand the population of cancer patients experiencing extended remissions The pre-clinical studies showed IMX-110 turns “cold” tumors …

BeiGene Signs a Clinical Trial Agreement with ImmixBio to Evaluate IMX-110 + Tislelizumab in Solid Tumors Read More »

Innovent Collaborates with Bolt to Develop Three Oncology Boltbody ISAC Programs

Shots: Bolt to receive $5M up front in cash & $10M as an equity investment. Both companies will receive milestones & royalties on the development & commercialization of products in each other’s territories Innovent gets rights to all 3 programs in Greater China & holds an option to get WW license rights for 1 program …

Innovent Collaborates with Bolt to Develop Three Oncology Boltbody ISAC Programs Read More »

NovaRock Signs an Exclusive License Agreement with Flame to Co-Develop and Commercialize NBL-015

Shots: NovaRock to receive $7.5M up front and is eligible to receive ~$633M as development & sales milestones along with royalties on the sales of the licensed products in the Territory Flame gets the exclusive rights to NBL-015 for pancreatic and gastric cancer outside of Greater China including mainland China, Hong Kong, Macau, and Taiwan …

NovaRock Signs an Exclusive License Agreement with Flame to Co-Develop and Commercialize NBL-015 Read More »

Lilly Signs a License Agreement with Lycia to Develop Novel LYTAC Degraders

Shots: Lycia to receive $35M up front and is also eligible to receive an additional ~$1.6B upon the achievement of milestones along with royalties on sales of the product emerges from the collaboration Lilly will be responsible for the pre/clinical development of the product and also gets an exclusive global license to commercialize the product …

Lilly Signs a License Agreement with Lycia to Develop Novel LYTAC Degraders Read More »

Vertex Expands its 2018 Agreement with Arbor to Develop Novel Ex Vivo Engineered Cell Therapies

Shots: Arbor to receive an up front in cash & is eligible to receive an additional ~$1.2B on achievement of milestones across up to 7 programs along with royalties on sales on products emerges from the collaboration. Vertex will also invest in Arbor in the form of a convertible note Vertex get rights to use …

Vertex Expands its 2018 Agreement with Arbor to Develop Novel Ex Vivo Engineered Cell Therapies Read More »

Roche Signs a License Agreement with Shape to Advance AAV-based RNA Editing Technology for Neuroscience and Rare Disease

Shots: Shape is eligible to receive $3B+ including initial payment, development, regulatory, and sales milestone along with royalties on sales of therapies resulting from the collaboration The collaboration will utilize Shape’s RNA editing platform i.e., RNAfix and AAVid for next-generation tissue-specific AAVs to develop gene therapy for AD, PD & rare diseases Shape to conduct …

Roche Signs a License Agreement with Shape to Advance AAV-based RNA Editing Technology for Neuroscience and Rare Disease Read More »

Orion Signs a License and Research Agreement with Alligator to Develop Bispecific Antibody for the Treatment of Cancer

Shots: Alligator to receive up front & research support payments. If Orion exercises its options to continue the development and commercialization of the product then Alligator will be further eligible to receive $548.41M as development, approval, and sales milestone for all three product candidates along with royalties The focus of the collaboration is to discover …

Orion Signs a License and Research Agreement with Alligator to Develop Bispecific Antibody for the Treatment of Cancer Read More »

BMS Exercises its Option to Develop Exscientia’s AI-Designed Drug Candidate

Shots: Exscientia to receive $20M as an option exercise fee and is eligible for development milestones along with royalties on any product sales BMS has elected to in-license an Exscientia’s immune-modulating drug candidate & will be responsible for clinical and commercial development of the product In May’21, the companies have expanded the collaboration to accelerate …

BMS Exercises its Option to Develop Exscientia’s AI-Designed Drug Candidate Read More »

5-Step Guide to Hiring AI Talent for Digital Health, Biotech & Life Sciences Companies

Michael Delisle, VP, Practice Leader for Digital Health at GattiHR Artificial Intelligence (AI) will disrupt healthcare’s destiny for good. Here are five steps digital health startups can take to find the premier talent to get the job done.  Not too long ago, AI was the topic of futuristic movies. What was once a fictional draw …

5-Step Guide to Hiring AI Talent for Digital Health, Biotech & Life Sciences Companies Read More »

Health Innovators: PureTech Health’s Daphne Zohar

In latest episode of our Health Innovators video interview series, Dr Paul Tunnah speaks to Daphne Zohar, the co-founder and CEO of PureTech Health. They discuss the publicly-listed biotech’s pipeline projects and focus on the BIG (brain-immune-gut) axis as well as PureTech’s interest in digital therapeutics. Daphne explains how she built an impressive team of board …

Health Innovators: PureTech Health’s Daphne Zohar Read More »

Exelixis Expands its Collaboration with Invenra to Develop Novel Biologics in Oncology

Shots: Invenra to receive $15.0M up front along with additional fees and funding to elect up to 20 additional targets in oncology & is eligible for development, regulatory, and commercial milestones along with royalties on net sales of any approved products Exelixis will own all Ab sequences discovered from the collaboration for uses in oncology …

Exelixis Expands its Collaboration with Invenra to Develop Novel Biologics in Oncology Read More »

Incyte Signs a License Agreement with InnoCare to Develop and Commercialize Tafasitamab in Greater China

Shots: Incyte to receive $35M up front & is eligible to receive an additional ~$82.5M as development, regulatory & commercial milestones along with royalties. The collaboration will accelerate the development of tafasitama in China InnoCare to obtain rights to develop & exclusively commercialize tafasitamab in hematology & oncology in mainland China, Hong Kong, Macau & …

Incyte Signs a License Agreement with InnoCare to Develop and Commercialize Tafasitamab in Greater China Read More »

Seagen Signs an Exclusive WW License Agreement with RemeGen to Develop and Commercialize Disitamab Vedotin

Shots: RemeGen to receive $200M up front for development and commercialization rights of disitamab vedotin outside of Remegen’s territory & ~$2.4B upon the achievement of milestones across multiple indications along with royalties on sales of the therapy in Seagen’s territory RemeGen will retain development & commercialization rights of the therapy in Asia (Ex-Japan & Singapore). …

Seagen Signs an Exclusive WW License Agreement with RemeGen to Develop and Commercialize Disitamab Vedotin Read More »

AbbVie Receives $20M Milestone in its DUB Targets Collaboration with Mission to Treat Alzheimer and Parkinson Diseases

Shots: AbbVie selects two DUB targets to advance it to the next stage of drug discovery based on the results from in vitro & in vivo studies for which Mission will receive a $20M as milestones As per 2018 agreement, the companies collaborated to identify novel DUB targets and discover associated inhibitor compounds for neurodegenerative …

AbbVie Receives $20M Milestone in its DUB Targets Collaboration with Mission to Treat Alzheimer and Parkinson Diseases Read More »

AbbVie Terminates its License Agreement with Molecular Partners for Abicipar Pegol

Shots: AbbVie has terminated the license agreement for abicipar pegol to treat nAMD and DME. Additionally, Molecular Partners will reacquire the development and commercial rights of abicipar globally Molecular Partners will put a special committee to assess the program & figure out the next steps. Additionally, the companies will continue the ongoing discovery collaboration to …

AbbVie Terminates its License Agreement with Molecular Partners for Abicipar Pegol Read More »

Kite Signs a License Agreement with Appia to Develop Allogeneic Cell Therapies for the Treatment of Cancer

Shots: Appia Bio to receive $875M as an up front, equity investment, and milestone along with royalties. Kite will be responsible for the development, manufacturing, and commercialization of the product identified through the collaboration The collaboration will utilize Kite’s chimeric Ag receptors and Appia Bio’s allogeneic cell technology platform to develop off-the-shelf cell therapies Appia …

Kite Signs a License Agreement with Appia to Develop Allogeneic Cell Therapies for the Treatment of Cancer Read More »

AstraZeneca Signs an Exclusive License Agreement with Sierra for AZD5153 to Treat Myelofibrosis

Shots: AstraZeneca to receive up front & development, regulatory and commercial milestones along with royalties. The agreement will provide a novel compound into Sierra’s pipeline to supply therapies for patients with rare cancers Sierra plans to initiate a P-II study of momelotinib (JAK inhibitor) + AZD5153 (BRD4 BET inhibitor) in patients with myelofibrosis & will …

AstraZeneca Signs an Exclusive License Agreement with Sierra for AZD5153 to Treat Myelofibrosis Read More »

Schrödinger Signs a R&D Collaboration with Zai Lab for Oncology Program Targeting DNA Damage Response

Shots: Schrödinger to receive up front to fund the share of research costs & is also eligible to receive ~$338M in pre/ clinical, regulatory & sales-based milestones along with royalties on sales outside the US Zai will be responsible for the global development, manufacturing, and commercialization of the selected candidates. Schrödinger will be eligible for …

Schrödinger Signs a R&D Collaboration with Zai Lab for Oncology Program Targeting DNA Damage Response Read More »

Tachyon Collaborates with AbCellera to Develop Novel Antibody Therapies Targeting TGF-β Superfamily Member for Cancer

Shots: AbCellera to receive milestones and royalties on products that are derived from its Ab discovery platform. Additionally, AbCellera has the option to invest in pre/ clinical development in exchange for an increased share of product sales The collaboration will accelerate the translation of a novel research & cancer drug target into a first-in-class Ab …

Tachyon Collaborates with AbCellera to Develop Novel Antibody Therapies Targeting TGF-β Superfamily Member for Cancer Read More »

Marinus Signs an Agreement with Orion for the Commercialization of Ganaxolone in EU

Shots: Marinus to receive ~$30M up front & is eligible to receive ~$115M in R&D reimbursement milestone on achievement of clinical & commercialization milestones along with royalties. The transaction is expected to be completed in Q1’22 Orion gets exclusive rights to commercialize ganaxolone as PO & IV formulations in EU, UK & Switzerland for CDD, …

Marinus Signs an Agreement with Orion for the Commercialization of Ganaxolone in EU Read More »

Ipsen Signs an Exclusive Collaboration with Exicure to Develop SNA-Based Therapeutics for Rare Neurodegenerative Disorders

Shots: Exicure to receive a $20M up front and will be eligible to receive ~$1B in option exercise fees and milestones along with royalties, if Ipsen exercises its option Exicure will be responsible for the discovery and pre-clinical development activities while Ipsen will lead further development and commercialization of the licensed product after exercising the …

Ipsen Signs an Exclusive Collaboration with Exicure to Develop SNA-Based Therapeutics for Rare Neurodegenerative Disorders Read More »

Takeda and Frazier Collaborate to Launch HilleVax (biopharma company) for the Development of Norovirus Vaccine

Shots: HilleVax gets an exclusive license for the development and commercialization rights of Takeda’s HIL-214 globally (Ex-Japan). Takeda will hold the commercialization rights of the vaccine in Japan Takeda will focus primarily on dengue, COVID-19, pandemic influenza and Zika vaccines. HilleVax will merge Japan development activities into its global development HIL-214 is a VLP based …

Takeda and Frazier Collaborate to Launch HilleVax (biopharma company) for the Development of Norovirus Vaccine Read More »

Astellas Signs a License Agreement with Minovia for Novel Mitochondrial Cell Therapy Programs

Shots: Minovia receives a $20M up front and is eligible to receive ~$420M per product in development, regulatory & commercial milestone for mitochondrial cell therapies caused by mitochondrial dysfunction The collaboration is to accelerate the allogeneic mitochondrial cell therapy programs & extend Astellas’ capabilities in mitochondrial biology. The collaboration follows the recent acquisition of Mitobridge …

Astellas Signs a License Agreement with Minovia for Novel Mitochondrial Cell Therapy Programs Read More »

Alnylam Signs a License Agreement with PeptiDream to Develop and Commercialize Peptide-siRNA Conjugates for Delivery of RNAi Therapeutics to a Broader Range of Extrahepatic Tissues

Shots: PeptiDream to receive an upfront along with R&D funding and may eligible for ~$2.2B in development, regulatory, and commercial milestones upon specified achievement along with royalties on sales on any Alnylam products The agreement will utilize PeptiDream’s peptide discovery platform with Alnylam’s siRNA-conjugate-based delivery to identify peptide ligands The collaboration will helps to yield …

Alnylam Signs a License Agreement with PeptiDream to Develop and Commercialize Peptide-siRNA Conjugates for Delivery of RNAi Therapeutics to a Broader Range of Extrahepatic Tissues Read More »

Lilly Collaborates with Kumquat to Develop Novel Small Molecules that Enhance Tumor-Specific Immune Responses

Shots: Kumquat to receive an ~ $70M in upfront and an equity investment in addition to ~$2B in milestone based on the achievement of definite milestones along with royalties on sales of commercialized products resulting from the collaboration Following the agreement, Lilly gets the option to co-commercialize in China while Kumquat has the option to …

Lilly Collaborates with Kumquat to Develop Novel Small Molecules that Enhance Tumor-Specific Immune Responses Read More »

Arena and Aristea Collaborate to Develop RIST4721 for Treatment of Complicated Immune-Mediated Inflammatory Diseases

Shots: Aristea to receive $60M as up front and $10M as equity investment in Aristea’s Series B financing. Arena gets an exclusive option to acquire Aristea, including rights to all CXCR2 programs, post completion of the P-IIb study of RIST4721 in PPP The companies can jointly explore the development of additional neutrophil-mediated diseases, including HS …

Arena and Aristea Collaborate to Develop RIST4721 for Treatment of Complicated Immune-Mediated Inflammatory Diseases Read More »

AbbVie and Calico Expand its Existing Collaboration to Focus on Aging and Age-Related Diseases

Shots: The collaboration will extend in 2022 for an additional 3yrs. Calico will lead R&D until 2025 & will advance projects into P-IIa through 2030 while AbbVie will support Calico in its early R&D efforts, following the completion of P-IIa studies, will get the option to manage late-stage development & commercial activities Both the companies …

AbbVie and Calico Expand its Existing Collaboration to Focus on Aging and Age-Related Diseases Read More »

PeptiDream and Takeda Expand its Research and License Agreement to Develop Peptide Drug Conjugates Targeting CNS Diseases

Shots: As per expanded collaboration, PeptiDream to receive ~$3.5B as up front, preclinical, development, launch, and commercial milestones and is eligible to receive royalties on sales of any product that emerges from the collaboration The extended collaboration expands the use of the TfR1 binding peptide ligands for CNS targets associated with neurodegeneration & allow Takeda …

PeptiDream and Takeda Expand its Research and License Agreement to Develop Peptide Drug Conjugates Targeting CNS Diseases Read More »

BioNTech Plans to Initiate the Clinical Study of Malaria and Tuberculosis Vaccines in 2022

Shots: BioNTech unveils the plan to develop the first mRNA-based vaccine to prevent malaria with anticipated initiation of the clinical study by the end of 2022 The company intends to set up a large vaccine production hub in Africa with the help of local partners and transfer its mRNA technology to Africa. These efforts of …

BioNTech Plans to Initiate the Clinical Study of Malaria and Tuberculosis Vaccines in 2022 Read More »

Adagio Collaborates with Biocon to Provide COVID-19 Ab Treatment to Patients in India and Other Emerging Markets

Shots: The companies collaborated for Adagio’s ADG20 for both the treatment & prevention of COVID-19 as monothx. or combination regimen Biocon will gain rights to manufacture & commercialize ADG20 for COVID-19 in India and select emerging markets based on the commercial process developed for ADG20. The company will have the access to Adagio’s ongoing P-II/III …

Adagio Collaborates with Biocon to Provide COVID-19 Ab Treatment to Patients in India and Other Emerging Markets Read More »

Denali Reports Results of DNL310 in P-I/II Study in Patients with the Lysosomal Storage Disease Hunter Syndrome (MPS II)

Shots: Denali reports data from the P-I/II study evaluating DNL310 (qw, IV) for both CNS and peripheral MPS II. All patients received doses of DNL310 after switching from idursulfase enzyme replacement therapy on Day 1 Results of Cohorts A & B showed the levels of heparan sulfate in CSF normalized in all patients analyzed with …

Denali Reports Results of DNL310 in P-I/II Study in Patients with the Lysosomal Storage Disease Hunter Syndrome (MPS II) Read More »

AstraZeneca’s Vaxzevria Demonstrates Effectiveness After One Dose Against Beta/Gamma and Delta Variants of SARS-CoV-2 Virus

Shots: RWE data from CIRN with support from the Public Health Agency of Canada and the Canadian Institutes of Health Research demonstrated that one dose of Vaxzevria was 82% effective against hospitalization or death caused by the Beta/Gamma variants of the SARS-CoV-2 virus The vaccine also demonstrated effectiveness against the Delta and Alpha variants with …

AstraZeneca’s Vaxzevria Demonstrates Effectiveness After One Dose Against Beta/Gamma and Delta Variants of SARS-CoV-2 Virus Read More »

ImaginAb Signs a Multi-Year Non-Exclusive License Agreement with Boehringer Ingelheim for CD8 ImmunoPET Technology

Shots: ImaginAb to receive license fees for providing ongoing technical, clinical, and regulatory support to facilitate the successful implementation of its CD8 ImmunoPET technology Following the new agreement, ImaginAb will supply clinical doses of 89Zr CD8 Immuno-PET technology to Boehringer Ingelheim for use in the clinical development of its novel oncology therapeutics throughout North America …

ImaginAb Signs a Multi-Year Non-Exclusive License Agreement with Boehringer Ingelheim for CD8 ImmunoPET Technology Read More »

Synaffix Signs a License Agreement with ProfoundBio for ADC Technologies

Shots: Synaffix is eligible to receive $246M upfront & milestones along with royalties on net sales. ProfoundBio to get non-exclusive license rights to use Synaffix’s ADC technologies for one therapeutic program to targets specific TAA & also retains license option rights to a second TAA The agreement will access Synaffix’s linker-payload technologies including GlycoConnect & …

Synaffix Signs a License Agreement with ProfoundBio for ADC Technologies Read More »

Relmada In-Licenses Psilocybin Program from Arbormentis

Shots: Arbormentis to receive $51M upfront in cash and equity in addition to $150M as milestone related to pre-specified development and commercialization milestones along with royalties on any commercialized therapy resulting from the collaboration Relmada acquires the development & commercial rights for psilocybin and derivate program from Arbormentis in all Ex-Asia countries, including the US …

Relmada In-Licenses Psilocybin Program from Arbormentis Read More »

BioNTech Signs a Purchase Agreement to Acquire Kite’s Cell Therapy, R&D Platform and Manufacturing Facility in Gaithersburg, MD

Shots: Kite will receive a one-time upfront to purchase Kite’s individualized solid tumor neoantigen TCR discovery platform, R&D & clinical manufacturing facility in Gaithersburg. The Transaction is expected to be close at the end of Jul’21 BioNTech will use the Kite’s facility to support clinical trials in the US & will add its cell therapy …

BioNTech Signs a Purchase Agreement to Acquire Kite’s Cell Therapy, R&D Platform and Manufacturing Facility in Gaithersburg, MD Read More »

AstraZeneca Signs an Exclusive WW License Agreement with Aridis for Suvratoxumab to Prevent Pneumonia

Shots: AstraZeneca to receive $11M up front in cash and Aridis common stock. & will also receive ~ $115M upon the achievement of development and commercial milestones along with royalties on net sales. Aridis received ~$30M funding for the P-III trial of suvratoxumab from the EU Commission’s IMI Aridis obtains exclusive rights for the development …

AstraZeneca Signs an Exclusive WW License Agreement with Aridis for Suvratoxumab to Prevent Pneumonia Read More »

Merck’s Vaxneuvance (pneumococcal 15-valent conjugate vaccine) Receives the US FDA’s Approval for the Prevention of Invasive Pneumococcal Disease Caused by 15 Serotypes

Shots: The approval is based on seven P-II & III clinical studies involves assessing the safety, tolerability & immunogenicity of Vaxneuvance vs PCV13 in 7,438 adults aged >18yrs. with IPD caused by 15 serotypes Results: Vaxneuvance showed a non-inferior immune response to PCV13 for 13 shared serotypes as assessed by OPA GMTs & superior immune …

Merck’s Vaxneuvance (pneumococcal 15-valent conjugate vaccine) Receives the US FDA’s Approval for the Prevention of Invasive Pneumococcal Disease Caused by 15 Serotypes Read More »

Eli Lilly Signs an Agreement with Banner Alzheimer’s Institute to Evaluate Donanemab in P-III TRAILBLAZER-ALZ 3 Trial for Alzheimer’s Disease

Shots: The collaboration is a part of the planned P-III TRAILBLAZER-ALZ 3 trial of donanemab vs PBO in patients with cognitive & functional decline related to AD. The study will assess if therapy slows the clinical progression of AD Banner will support the enrollment of trial participants with & without e4 type of APOE4 gene …

Eli Lilly Signs an Agreement with Banner Alzheimer’s Institute to Evaluate Donanemab in P-III TRAILBLAZER-ALZ 3 Trial for Alzheimer’s Disease Read More »

Skyhawk Collaborate with Aragen to Develop Novel Small Molecule Therapeutics to Correct RNA Expression

Shots: Skyhawk collaborated with Aragen for the development of small molecule therapeutics that correct RNA expression Under the collaboration, Skyhawk will get multiple discovery chemistry and biology service solutions from Aragen The alliance focuses to accelerate Skyhawk’s research pipeline. Aragen’s research expertise will help Skyhawk to advance the development of its novel small molecule therapeutics …

Skyhawk Collaborate with Aragen to Develop Novel Small Molecule Therapeutics to Correct RNA Expression Read More »

Heat Biologics Signs a Research License Agreement with ProBioGen for Transposase System and Suspension HEK293 Cell Line

Shots: ProBioGen collaborates with Heat Biologics for both ProBioGen’s DirectedLuck Transposase System along with suspension HEK293 cell line The DirectedLuck Transposase is well-matched with additional genetic elements in standard expression vector design and can be used with any host cell line ProBioGen’s HEK293 has been developed for the manufacture of proteins and viral vectors and …

Heat Biologics Signs a Research License Agreement with ProBioGen for Transposase System and Suspension HEK293 Cell Line Read More »

Astellas Signs a License Agreement with ExCellThera for In Vitro Use of UM171 in Pluripotent Stem Cells

Shots: ExCellThera to receive up front, future contingent payments along with manufacturing and supply fees for the licensed molecules The collaboration validates the immense clinical and commercial potential of UM171 in additional fields of development The collaboration allows the ExcelThera to focus on clinical programs and commercial plans for ECT-001 cell therapy product along with …

Astellas Signs a License Agreement with ExCellThera for In Vitro Use of UM171 in Pluripotent Stem Cells Read More »

Ionis Signs an Exclusive WW License Agreement with Bicycle to Develop Targeted Oligonucleotide Therapeutics Using TfR1 Bicycle Technology

Shots: Bicycle receives $45M as up front and is eligible to receive development, regulatory and commercial milestones along with royalties for each program developed under the collaboration Ionis exercised its option for an exclusive license under the terms of a Dec’2020 evaluation and option agreement and get rights to evaluate tissue-targeting TfR1 binding Bicycles as …

Ionis Signs an Exclusive WW License Agreement with Bicycle to Develop Targeted Oligonucleotide Therapeutics Using TfR1 Bicycle Technology Read More »

Novo Nordisk to Acquire Prothena’s ATTR Amyloidosis Program for ~$1.2B

Shots: Prothena is eligible to receive ~$1.2B as development and commercial milestones including $100M as up front and near-term clinical milestones Novo Nordisk acquires Prothena’s subsidiary and gets WW rights to the IP and related rights of Prothena’s ATTR amyloidosis business and pipeline. Novo Nordisk will develop the P-II ready Ab PRX004 for ATTR cardiomyopathy …

Novo Nordisk to Acquire Prothena’s ATTR Amyloidosis Program for ~$1.2B Read More »

Janssen Collaborates with Vor to Develop Engineered Hematopoietic Stem Cell Transplants with Bi-Specific Antibody Therapy to Treat AML

Shots: The collaboration will evaluate the combination of Vor’s eHSC transplant platform with Janssen’s bi-specific Abs for the treatment of AML The agreement stated that each company retains all rights and ownership to their respective programs and platforms The combination will utilize each technology’s strengths for protecting patients against off-target effects of immunotherapies Click here to …

Janssen Collaborates with Vor to Develop Engineered Hematopoietic Stem Cell Transplants with Bi-Specific Antibody Therapy to Treat AML Read More »

Lilly Signs a Three-Year Collaboration with Verge Genomics to Discover and Develop Novel Therapies for ALS

Shots: Verge to receive ~$25M as up front, equity investment, and near-term payments in addition to ~$694M as milestone and royalties The collaboration will utilize Verge’s AI-driven all-in-human platform to identify new targets. Lilly may select up to four identified targets to advance it into clinical development and commercialization Verge Genomics retains all rights to …

Lilly Signs a Three-Year Collaboration with Verge Genomics to Discover and Develop Novel Therapies for ALS Read More »

AstraZeneca Signs an Exclusive License Agreement with F-star Therapeutics for Novel STING Inhibitors

Shots: F-star is eligible to receive up front and near-term payments of ~$12M & will be eligible for ~$300M as development & sales milestone along with royalties. Payments received by F-star are subject to a CVR agreement in which a portion will be payable to F-star’s investors that were previously stockholders of Spring Bank AstraZeneca …

AstraZeneca Signs an Exclusive License Agreement with F-star Therapeutics for Novel STING Inhibitors Read More »

BeiGene Signs a Supply Agreement with PureTech for LYT-200 and Tislelizumab in Patients with Difficult-to-Treat Solid Tumors

Shots: The companies collaborated to evaluate BeiGene’s tislelizumab (anti-PD-1 immune checkpoint inhibitor) + PureTech’s LYT-200 (mAb targeting galectin-9) in patients with solid tumors associated with poor survival rates LYT-200 is currently being evaluated as a monothx in an adaptive P-I/II clinical trial. PureTech is expected to report the P-I results from LYT-200 monothx in Q4’21 …

BeiGene Signs a Supply Agreement with PureTech for LYT-200 and Tislelizumab in Patients with Difficult-to-Treat Solid Tumors Read More »

Roche Enters into a Clinical Collaboration with Treos Bio for PolyPEPI1018 + atezolizumab in P-I/II Trial to Treat Late Stage Microsatellite Stable Metastatic Colorectal Cancer

Shots: The companies collaborated to evaluate Treos’ PolyPEPI1018 (Polypeptide cancer immunotherapy) + Roche’s atezolizumab (PD-L1-inhibitor) in P-I/II trial in patients with late-stage MSS mCRC which is expected to initiate in Q4’21 Treos has completed a P- I/II OBERTO 101 study for PolyPEPI1018 as 1L maintenance setting in patients with MSS mCRC that demonstrates the therapy …

Roche Enters into a Clinical Collaboration with Treos Bio for PolyPEPI1018 + atezolizumab in P-I/II Trial to Treat Late Stage Microsatellite Stable Metastatic Colorectal Cancer Read More »

Chugai Files an Application with MHLW for an Additional Indication of Tecentriq as an Adjuvant Treatment for NSCLC in Japan

Shots: The filing is based on the results from the P-III IMpower010 study assessing Tecentriq (1200mg, IV) vs BSC in 1,005 patients in a ratio (1:1) with Stage IB-IIIA NSCLC, following surgical resection and up to 4 cycles of adjuvant cisplatin-based CT Results: 34% reduction in risk of disease recurrence or death in people with …

Chugai Files an Application with MHLW for an Additional Indication of Tecentriq as an Adjuvant Treatment for NSCLC in Japan Read More »

Sanofi Signs ~$1B Agreement with Eureka & MSK for their Multiple Myeloma Candidate

Shots: Eureka and MSK are eligible to receive up front and ~$1B as development, regulatory and sales milestone along with royalties on net sales. Sanofi gets exclusive rights to the GPRC5D binder for non-CAR use Eureka discovered the GPRC5D binding domain using its E-ALPHA Abs discovery platform, under its collaboration with MSK Additionally, targeting GPRC5D …

Sanofi Signs ~$1B Agreement with Eureka & MSK for their Multiple Myeloma Candidate Read More »

Roche Enter into a Collaboration with Mimetas to Develop Human Disease Models for Drug Development

Shots: Mimetas is eligible to receive up front and milestones while Roche will get an option to exclusively license specific disease models and assays for use in drug discovery in IBD and HBV infections Mimetas will be responsible for developing tissue-based disease models and assays in the OrganoPlate that help to increases the predictability of …

Roche Enter into a Collaboration with Mimetas to Develop Human Disease Models for Drug Development Read More »

Imugene HER2 vaccine hits target in stomach cancer trial

A peptide vaccine developed by Australia’s Imugene has reduced tumour size in around half of patients with HER2-positive gastric or gastroesophageal junction (GEJ) cancer in a phase 2 trial. The interim readout from the 39-patient HERIZON trial found 50% of patients treated with the HER-Vaxx (IMU-131) vaccine on top of chemotherapy achieved a partial response …

Imugene HER2 vaccine hits target in stomach cancer trial Read More »

UK biotech ‘booming’ as sector rakes in £1.6bn in Q2 financing

The UK’s biotechnology sector is going through a purple patch, attracting almost £1.6 billion ($2.2 billion) in financing in the three months to end-May – which is a record for the industry. The new figures – from the BioIndustry Association and Clarivate – were dominated by more than £1 billion in venture capital funding for …

UK biotech ‘booming’ as sector rakes in £1.6bn in Q2 financing Read More »

Spero Therapeutics Enters into a License Agreement with Pfizer for SPR206 to Treat MDR Gram Negative Infections

Shots: Spero is eligible to receive $40M as an equity investment and ~$80M as development & sales milestones along with royalties on sales of SPR206 in licensed countries. Pfizer gets rights to develop, manufacture & commercialize SPR206 in ex-US & ex-Asia As per the 2019 licensing agreement with Spero, Everest Medicines has exclusive rights to …

Spero Therapeutics Enters into a License Agreement with Pfizer for SPR206 to Treat MDR Gram Negative Infections Read More »

Merck Amends Collaboration with NGM to Advance Novel Therapies for Retinal and CVM Diseases

Shots: NGM to receive ~ $120M as research & development funding through Mar’24, including ~$86M for the period from Apr’21 through Mar’22 & additional option payments if Merck exercises license option The collaboration will initially focus on retinal and CVM diseases with NGM621 and MK-3655. Merck retains its option to license NGM621, currently being evaluated …

Merck Amends Collaboration with NGM to Advance Novel Therapies for Retinal and CVM Diseases Read More »

GSK and Alector Sign $2.2B Collaboration to Develop Therapies for Neurodegenerative Diseases

Shots: Alector to receive $700M as up front and is eligible to receive ~$1.5B as milestones. The companies collaborated to co-develop AL001 and AL101 for frontotemporal dementia, ALS, PD and AD Alector will lead the development of the therapies through P-II POC while the companies will share development costs for therapies. The companies will co-commercialize …

GSK and Alector Sign $2.2B Collaboration to Develop Therapies for Neurodegenerative Diseases Read More »

Nestle and Seres Collaborate to Jointly Commercialize SER-109 for Recurrent Clostridioides difficile Infection

Shots: Seres to receive $175M up front, $125M upon the US FDA’s approval of SER-109 along with ~$225M as a commercial milestone. Seres will be responsible for development & pre-commercialization costs in the US and will be entitled to 50% of the commercial profits The agreement includes co-commercialization of microbiome therapeutics in the US and …

Nestle and Seres Collaborate to Jointly Commercialize SER-109 for Recurrent Clostridioides difficile Infection Read More »

Pharma’s use of synthetic biology could deliver radical innovation

Synthetic biology holds much promise for the life sciences sector as it continues to look for new ways of treating disease and accelerating drug development, says Debiopharm’s Tanja Dowe. Synthetic biology has grown exponentially in less than a decade, with CRISPR gene-editing as the key technology driving this through its use in areas like cancer, …

Pharma’s use of synthetic biology could deliver radical innovation Read More »

Pharma’s use of synthetic biology could deliver radical innovation

Synthetic biology holds much promise for the life sciences sector as it continues to look for new ways of treating disease and accelerating drug development, says Debiopharm’s Tanja Dowe. Synthetic biology has grown exponentially in less than a decade, with CRISPR gene-editing as the key technology driving this through its use in areas like cancer, …

Pharma’s use of synthetic biology could deliver radical innovation Read More »

Health Tech, Part I: Where We Are Going, Not Just How Fast We Can Get There

By MIKE MAGEE What will be the lasting impact of the Covid 19 pandemic? We still don’t know the answer to that question in full. But one thing that can be said with some certainty is that it has strengthened the hand of Big Tech and all things virtual. Consider the fact that within the …

Health Tech, Part I: Where We Are Going, Not Just How Fast We Can Get There Read More »

Lineage Signs an Exclusive Option Agreement with Amasa Therapeutics to Supply and Use of Clinical-Grade Hystem

Shots: Lineage to receive an upfront payment in cash and, if the option is exercised, Lineage will be eligible for additional payments, including event-specific payments, royalties on net sales and sublicense fees and royalties Amasa gets an exclusive option to royalty-bearing license to use Lineage’s HyStem technology to develop and commercialize therapies for solid tumors …

Lineage Signs an Exclusive Option Agreement with Amasa Therapeutics to Supply and Use of Clinical-Grade Hystem Read More »

BioNTech Reports First Patient Dosing in P-II Clinical Trial of BNT111 to Treat Advanced Melanoma

Shots: The first patient has been dosed in a P-II cancer vaccine trial evaluating the efficacy, tolerability & safety of BNT111 + Libtayo in combination or as monothx in 120 patients with anti-PD1 r/r unresectable Stage III or IV melanoma in EU. The company also plans to start P-II trial in 2 additional programs with …

BioNTech Reports First Patient Dosing in P-II Clinical Trial of BNT111 to Treat Advanced Melanoma Read More »

Kite Enter into a Partnership with Shoreline Biosciences to Develop Novel Allogeneic Cell Therapies

Shots: Shoreline is eligible to receive ~$2.3B including upfront, development and commercialization milestones and additional payments along with royalties. The agreement follows Kite’s investment in Shoreline’s recent Series A financing The collaboration will utilize Shoreline’s iPSC differentiation and genetic reprogramming with Kite’s cell therapy to develop novel allogeneic therapies for hematologic malignancies Initially, the collaboration …

Kite Enter into a Partnership with Shoreline Biosciences to Develop Novel Allogeneic Cell Therapies Read More »

Lundbeck Presents Results of Vyepti (eptinezumab-jjmr) in RELIEF Study for Preventive Treatment of Migraine at JAMA

Shots: The RELIEF study evaluating the efficacy & safety of VYEPTI (100mg, 30-minute IV infusion) vs PBO in a ratio (1:1) in 480 patients with migraine, administered within 1-6 hrs of migraine attack The study met its co-primary EPs i.e., median time to headache pain freedom (4 hrs vs 9 hrs) & median time to …

Lundbeck Presents Results of Vyepti (eptinezumab-jjmr) in RELIEF Study for Preventive Treatment of Migraine at JAMA Read More »

Cell Line Development and Characterization: An Ocean of Opportunities for Service Providers

The growing pipeline of monoclonal antibodies, vaccines, enzymes, biosimilars and other therapeutic proteins have created an ever- increasing demand for highly- productive and stable cell lines. Many of the recombinant biotherapeutic products, produced in cellular systems, have been translated into commercial successes; these include ALPROLIX®, ELOCTATE® and ELAPRASE®.  Given their impact on the overall quality …

Cell Line Development and Characterization: An Ocean of Opportunities for Service Providers Read More »

Gilead and Jounce’s JTX-1811 Receives US FDA’s IND Clearance for Cancer Immunotherapies

Shots: Jounce to receive $85M upfront and $35M in its common stock under the terms of Sep 2020 agreement. Additionally, it is eligible to receive upto $660M in future clinical, regulatory and commercial milestone payments along with royalties based upon the w/w sales after receiving a $25M milestone Jounce led the development of JTX-1811 through …

Gilead and Jounce’s JTX-1811 Receives US FDA’s IND Clearance for Cancer Immunotherapies Read More »

GSK Signs an Agreement with iTeos to Develop and Commercialize EOS-448 for Patients with Cancer

Shots: iTeos to receive $625M up front & is eligible to receive up to ~$1.45B in milestone upon achievement of certain milestones & royalties on ex-US sales. Both companies will share global development costs of EOS-448 and co-commercialize & share profits in the US GSK to receive an exclusive license for commercialization (Ex-US) & access …

GSK Signs an Agreement with iTeos to Develop and Commercialize EOS-448 for Patients with Cancer Read More »

Vertex and CRISPR Therapeutics Present New Data of CTX001 from 22 Patients with TDT and SCD at EMA 2021

Shots: The ongoing two P-I/ II studies, CLIMB-Thal-111 & CLIMB-SCD-121 evaluating CTX001 in 45 patients with a follow-up of ~2yrs. after infusion aged 18-35yrs to treat transfusion-dependent beta-thalassemia & sickle cell disease The results from 22 patients with a follow-up of >3 mos., i.e 15 patients with TDT are transfusion-free after CTX001 infusion @ follow-up …

Vertex and CRISPR Therapeutics Present New Data of CTX001 from 22 Patients with TDT and SCD at EMA 2021 Read More »

Antibody Purification: A Deeper Look into Service Providers Landscape

Over time, several innovative technologies have been developed to support the designing and manufacturing of various types of antibody products; however, the aforementioned processes are characterized by high costs and technical complexities, especially during the production and downstream processing steps. Therefore, it is challenging for new entrants and companies with limited resources and capital, to …

Antibody Purification: A Deeper Look into Service Providers Landscape Read More »

Pharmaceutical Manufacturing and Packaging Congress 2021

Pharmaceutical Manufacturing & Packaging Congress (PHARMAP 2021) will be held on the 28th – 29th of June, 2021 at the BGS online platform. CIOs and directors of pharmaceutical companies and laboratories, research and manufacturing directors, clinicians, IT project managers, heads from manufacturing and packaging pharma technology companies will gather to discuss the Manufacturing and Packaging …

Pharmaceutical Manufacturing and Packaging Congress 2021 Read More »

Takeda Expands its License Agreement with Codexis to Discover Novel Gene Therapies for Fourth Rare Genetic Disorders

Shots: The companies expanded their license agreement for the research and development of an additional gene therapy for a lysosomal storage disorder. Takeda has exercised its option to initiate a fourth program based on the results from three initial programs Following the Mar’2020 agreement, Codexis has created the novel enzyme sequences to advance gene therapies …

Takeda Expands its License Agreement with Codexis to Discover Novel Gene Therapies for Fourth Rare Genetic Disorders Read More »

BeiGene Signs an Exclusive Worldwide Collaboration with Shoreline to Develop and Commercialize Genetically Modified NK Cell Therapies

Shots: Shoreline to receive $45M up front in cash and is eligible to receive R&D funding, milestones along with royalties, following the achievement of certain milestones The companies will jointly develop cell therapies for four targets, with an option to further expand the collaboration. BeiGene will lead the clinical development globally while Shoreline will be …

BeiGene Signs an Exclusive Worldwide Collaboration with Shoreline to Develop and Commercialize Genetically Modified NK Cell Therapies Read More »

Hummingbird Collaborates with Novogene to Expand Precision Therapy Testing for NRG1-Fusion Driven Cancers in China

Shots: The partnership will utilize Novogene’s molecular diagnostics capabilities to expand patient identification by NGS in China for supporting the development of Hummingbird’s HMBD-001 which is expected to enter P-I study in 2021 to treat NRG1-fusion driven cancers The partnership focuses on validation and expansion of clinical-grade testing for NRG1 fusions in patient populations with …

Hummingbird Collaborates with Novogene to Expand Precision Therapy Testing for NRG1-Fusion Driven Cancers in China Read More »

Inovio Expands its Partnership with Advaccine to Initiate P-III Efficacy Trial for INO-4800 to Treat COVID-19

Shots: The companies collaborated to initiate a P-III trial to evaluate the safety & efficacy of INO-4800 (2.0mg, two-dose regimen, given at a gap of 1 mos.) in healthy men & non-pregnant women aged ≥18yrs. with COVID 19 across Latin American & Asia. The study expected to commence in summer across the globe The 1EPs …

Inovio Expands its Partnership with Advaccine to Initiate P-III Efficacy Trial for INO-4800 to Treat COVID-19 Read More »

AbbVie Collaborates with Caraway to Develop TMEM175 for Parkinson’s Disease and Other Related Disorders

Shots: Caraway to receive ~$267M including $17M up front in cash and remaining as option payment & milestones and is eligible for additional regulatory and commercial milestones along with royalties & gets the option to take part in product development in exchange for higher royalty rates Post pre-clinical research and development activities, AbbVie has an …

AbbVie Collaborates with Caraway to Develop TMEM175 for Parkinson’s Disease and Other Related Disorders Read More »

Immunocytokines – The Power of Fusion Proteins

Cancer is one of the leading causes of death worldwide, accounting for an estimated 0.6 million deaths in 2020, in the US alone. The World Health Organization has estimated the number of new cancer cases to rise by 70%, worldwide, over the next 20 years. It is a well-known fact that the conventional treatment options, …

Immunocytokines – The Power of Fusion Proteins Read More »

How Microsoft Teams streamlined cross-country forecasting for biotech pioneers.

J+D Forecasting has worked with one of Europe’s largest, leading biotechnology pioneers, helping to facilitate better, more collaborative forecasting for hundreds of colleagues across the continent. For the company’s most recent forecasting cycle, our experts have worked to incorporate Microsoft Teams as a core software, as well as extending Power BI, to enable regional users, and …

How Microsoft Teams streamlined cross-country forecasting for biotech pioneers. Read More »

Prostate Cancer Drug Development Summit

The inaugural Prostate Cancer Drug Development Summit is the only industry-led meeting uniting large pharma, biotech and pioneering academics with the ambitious objective of accelerating the clinical development of safe and effective therapies to treat prostate cancer. With sessions on both early and advanced stages of prostate cancer (Non-Metastatic Castrate-Resistant Prostate Cancer (nmCRPC) and Metastatic Castrate-Resistant Prostate Cancer (mCRPC), this is a conversation not …

Prostate Cancer Drug Development Summit Read More »

Senti Bio Collaborates with BlueRock to Develop Gene Circuit Engineered Cell Therapies for Regenerative Medicine

Shots: BlueRock to get an option to license gene circuits emerging from the collaboration for cell therapy products in specific indications. If option exercises, the company will be responsible for conducting pre/clinical and commercialization activities for any candidates incorporating Senti Bio’s licensed gene circuits Senti Bio will strengthen BlueRock’s cell+gene platform by developing gene circuits …

Senti Bio Collaborates with BlueRock to Develop Gene Circuit Engineered Cell Therapies for Regenerative Medicine Read More »

BMS and Xencor Collaborate to Use Xtend XmAb Technology in SARS-CoV-2 Neutralizing mAb Combination for COVID-19

Shots: BMS to get non-exclusive access to Xencor’s Xtend Fc technology to extend the half-life of a novel Ab combination therapy that is intended to neutralize the SARS-CoV-2 virus to prevent COVID-19 BMS will solely lead research, development, regulatory and commercial activities for SARS-CoV-2 mAb Duo. Xencor is eligible to receive royalties from the sales …

BMS and Xencor Collaborate to Use Xtend XmAb Technology in SARS-CoV-2 Neutralizing mAb Combination for COVID-19 Read More »

Boehringer Ingelheim to Develop Dicerna’s GalXC RNAi Candidate for NASH

Shots: Boehringer Ingelheim has accepted a GalXC RNAi candidate (DCR-LIV2) for advancement under the existing agreement b/w the companies for the discovery and development of novel therapies for chronic liver diseases Dicerna will receive $170M as development and commercial milestones related to DCR-LIV2 and is eligible to receive royalties on net sales of the therapy …

Boehringer Ingelheim to Develop Dicerna’s GalXC RNAi Candidate for NASH Read More »

Sarepta’s SRP-9001 Demonstrates Robust Expression and Safety Results in ENDEAVOR Study for DMD

Shots: Sarepta reported positive 12wks. expression & safety results from the first 11 participants enrolled in Study SRP-9001-103. The study uses commercially representative SRP-9001 Patients demonstrated robust transduction, with a mean micro-dystrophin expression of 55.4% of normal, as measured by western blot. Micro-dystrophin was properly localized to the muscle sarcolemma, with patients achieving a mean …

Sarepta’s SRP-9001 Demonstrates Robust Expression and Safety Results in ENDEAVOR Study for DMD Read More »

BMS Signs an Exclusive Global License with Agenus for its Anti-TIGIT Bispecific Antibody Program

Shots: Agenus to receive a $200M as up front & ~$1.36B as development, regulatory and commercial milestones plus royalties on net sales of the therapies. Agenus will retain options to conduct clinical studies and combination studies with other pipeline assets and to co-promote AGEN1777 in the US BMS will be solely responsible for the development …

BMS Signs an Exclusive Global License with Agenus for its Anti-TIGIT Bispecific Antibody Program Read More »

Key insights for a successful first-time product launch

Pre-commercial & Emerging pharma companies may not think they have the resources to match the launch strategies of big pharma. But with the proper planning and an agile approach, they can be more successful than they realise, says Veeva’s Ian Hale. He takes us through the challenges of a successful launch and explains what pre-commercial …

Key insights for a successful first-time product launch Read More »

Charles River to Acquire Vigene Biosciences for $292.5M

Shots: Charles River Laboratories to acquire Vigene in all cash transaction for $292.5M. In addition to the initial purchase price, the transaction includes contingent additional payments of up to $57.5M based on future performance The transaction is expected to be close in Q3’21. The acquisition will allow Charles River to boost its gene therapy capabilities …

Charles River to Acquire Vigene Biosciences for $292.5M Read More »

Biogen and Envisagenics Enter into a Collaboration for the Advancement of RNA Splicing Research to Treat Central Nervous System Diseases

Shots: Biogen will utilize Envisagenics’ SpliceCore, an AI- driven RNA splicing platform to understand the regulation of different RNA isoforms in CNS cell types and will be able to access SpliceCore’s database of ~7M RNA splicing errors providing a broader perspective to evaluate splicing events The collaboration will identify and validate disease genetic targets to …

Biogen and Envisagenics Enter into a Collaboration for the Advancement of RNA Splicing Research to Treat Central Nervous System Diseases Read More »

Dr Reddy’s Acquires an Exclusive License for Pregene’s PRG1801 in India

Shots: Pregene to receive $5M upfront and milestone for the 1st indication and $7.5M milestone for subsequent indications and is also eligible to receive $150M royalty on future sales of PRG1801 in the licensed countries Dr. Reddy’s will acquire the exclusive rights to commercialize PRG1801 in India and will be responsible for future development including …

Dr Reddy’s Acquires an Exclusive License for Pregene’s PRG1801 in India Read More »

Cellectis Collaborates with Sanofi for Alemtuzumab to be Utilized in CART-Cell Trials

Shots: The companies enter into a supply agreement for Alemtuzumab to be used in Cellectis’ trials as a lymphodepleting regimen for UCART22 in the BALLI-01 clinical trial to treat r/r ALL, and for UCART123 in AMELI-01 clinical trial to treat r/r AML but not for UCARTCS1 due to self-lymphodepleting activity Sanofi will provide alemtuzumab for …

Cellectis Collaborates with Sanofi for Alemtuzumab to be Utilized in CART-Cell Trials Read More »

Lilly Signs a ~$1.25B Research Collaboration with MiNA Therapeutics to Develop saRNA Therapies

Shota: MiNA to receive $25M as up front and is eligible to receive $245M as milestones for each of five potential targets along with royalties on product sales resulting from the collaboration Lilly will be responsible for the pre/ clinical development of candidates and will retain exclusive commercialization rights for any products emerges during the …

Lilly Signs a ~$1.25B Research Collaboration with MiNA Therapeutics to Develop saRNA Therapies Read More »

Biogen Collaborates with Capsigen to Discover Novel AAV Capsids for Targeted CNS and Neuromuscular Disorders

Shots: Capsigen to receive $15M up front and is eligible to receive up to ~$42M as research milestones and ~$1.25B as additional payments upon the achievement of development and sales milestones along with royalties on net sales of products resulting from the collaboration Biogen to get an exclusive license under Capsigen’s technology for CNS and …

Biogen Collaborates with Capsigen to Discover Novel AAV Capsids for Targeted CNS and Neuromuscular Disorders Read More »

AstraZeneca Reports Results of Imfinzi (durvalumab) and Imfinzi + Tremelimumab in P-III POSEIDON Study as 1L Treatment for Stage IV Non-Small Cell Lung Cancer

Shots: The P-III POSEIDON study involves assessing Imfinzi + platinum-based CT or Imfinzi + Tremelimumab + CT vs CT as monothx as a 1L treatment in patients with mNSCLC The study demonstrated improvement in OS and combination also showed improvement in PFS, as previously reported in Oct 2019. In a previous analysis, patients treated with …

AstraZeneca Reports Results of Imfinzi (durvalumab) and Imfinzi + Tremelimumab in P-III POSEIDON Study as 1L Treatment for Stage IV Non-Small Cell Lung Cancer Read More »

AbCellera Signs a Multi-Target Collaboration with Amgen to Develop Bispecific Antibodies for the Treatment of Diabetic Retinopathy

Shots: AbCellera will receive equity and research fees and is eligible to receive milestone along with royalties based on the development and commercialization of Abs Angios gets the rights to develop and commercialize therapeutic products resulting from the collaboration AbCellera will use an AI-powered platform to generate panels of Abs for up to three Angios-selected …

AbCellera Signs a Multi-Target Collaboration with Amgen to Develop Bispecific Antibodies for the Treatment of Diabetic Retinopathy Read More »

Sanofi Signs a Three-Year Collaboration with Stanford Medicine to Accelerate Immunology Research

Shots: Sanofi and Stanford Medicine collaborated to initiate three “deep-dive” research projects focusing on autoimmune diseases and inflammatory conditions The partners will organize a joint committee to fund three programs in a year with an annual research forum held by Sanofi for researchers from both organizations to further exchange ideas and discuss collaborative research projects …

Sanofi Signs a Three-Year Collaboration with Stanford Medicine to Accelerate Immunology Research Read More »

New UK biotech Inspira uncloaks with deal to develop inhaled COVID therapy

UK biotech Inspira Pharmaceuticals has emerged from stealth mode with a deal with Vectura to develop an inhaled therapy for COVID-19 that could be ready for human testing within 12 months.  The start-up is focusing on processed and purified extracts from an undisclosed plant source that have been shown in lab studies to kill the …

New UK biotech Inspira uncloaks with deal to develop inhaled COVID therapy Read More »

Exelixis Acquires GamaMabs’ Oncology Antibody Program to Expand its Biotherapeutics Portfolio

Shots: Exelixis to acquire GamaMabs’ AMHR2 Ab technology for $5M and additionally payment upon achieving certain milestones. Following the closing of the transaction, Exelixis will control GamaMabs’ AMHR2 franchise technology including all assets related to murlentamab (GM-102) The preclinical data support the potential of AMHR2 for novel oncology therapies and demonstrated the safety of an …

Exelixis Acquires GamaMabs’ Oncology Antibody Program to Expand its Biotherapeutics Portfolio Read More »

Athenex to Acquire Kuur Therapeutics for ~$185M

Shots: Kuur will receive $70M up front primarily in Athenex common stock and is eligible to receive ~$115 M as a milestone at Athenex’s sole discretion in either cash or additional Athenex common stock (or a combination of both) The acquisition will expand Athenex’s cell therapy development capability with Kuur’s off-the-shelf engineered CAR-NKT platform and …

Athenex to Acquire Kuur Therapeutics for ~$185M Read More »

Repertoire Collaborates with Yale University to Identify Novel Antigen and T- Cell Receptor for Multiple Sclerosis

Shots: Repertoire and Yale University collaborated to understand the immunological causes of MS by identifying the specificity of various subsets of T cells The focus of the agreement is to determine the specificity of T cells obtained from the CSF of patients living with MS and determine the pathogenic T cells driving MS and the …

Repertoire Collaborates with Yale University to Identify Novel Antigen and T- Cell Receptor for Multiple Sclerosis Read More »

BioMarin Collaborates with Allen Institute to Develop Gene Therapies for Rare Brain Diseases

Shots: BioMarin will receive an exclusive license to each program for research, development, and commercialization of the gene therapies The collaboration will utilize Allen institute technologies to develop new gene therapies for rare genetic diseases of CNS by targeting gene expression to specific cells Allen Institute has developed modified engineering AAVs to carry genes on …

BioMarin Collaborates with Allen Institute to Develop Gene Therapies for Rare Brain Diseases Read More »

LogicBio Signs an Option Agreement with Canbridge to Develop Gene Editing Therapies

Shots: LogicBio to receive $10M up front with ~$581M as option payment and milestones along with royalties. Canbridge to get an exclusive option to license LB-001 in Greater China and two additional undisclosed gene therapy programs. The agreement also grants CANbridge a WW license for AAV sL65 which is the first capsid produced from LogicBio’s …

LogicBio Signs an Option Agreement with Canbridge to Develop Gene Editing Therapies Read More »

InveniAI Collaborates with Shionogi on AI-Based Drug Discovery

Shots: InveniAI is eligible to receive up to $200M/ program as up front, development, and commercial milestones along with royalties The collaboration integrates InveniAI’s AI platform AlphaMeld to identify, evaluate, optimize novel targets with Shionogi’s expertise in developing and commercializing therapeutic modalities Shionogi will synthesize targets identified by InveniAI for certain strategic diseases and will …

InveniAI Collaborates with Shionogi on AI-Based Drug Discovery Read More »

Pieris Out-licenses PRS-342 to Boston Pharmaceuticals for ~$363M

Shots: Pieris to receive $10M upfront and is eligible to receive $353M in development, regulatory, and commercial based milestones along with royalties on sales of PRS-342. Pieris will also contribute an undisclosed amount for manufacturing activities Boston to get exclusive worldwide rights to develop PRS-342 and will be primarily responsible for the development of the …

Pieris Out-licenses PRS-342 to Boston Pharmaceuticals for ~$363M Read More »

Biotech and medical device companies raise $913M in a five-IPO week

The five life sciences IPOs this week continues the steady march companies are making to the public markets this year. This week’s activity follows a first quarter that Renaissance Capital calculates was the busiest for newly public companies since 2000. Healthcare IPOs continued to dominate the stock offerings.

Vertex Signs a License Agreement with Obsidian Therapeutics to Discover Regulated Gene Editing Therapies

Shots: Obsidian to receive $75M in equity, up front, research milestones and is eligible to receive ~$1.3B as research, development, regulatory, and commercial milestones across up to five potential programs. Additionally, Obsidian will receive royalties on sales of products that emerge from the collaboration Obsidian will deploy its cytoDRiVE platform to discover controllable genetic therapies …

Vertex Signs a License Agreement with Obsidian Therapeutics to Discover Regulated Gene Editing Therapies Read More »

Serimmune CEO: Leveraging the functional antibody repertoire will transform healthcare

In response to emailed questions, the CEO and CTO talk about the immune intelligence startups’ Human Immunity Map — a growing database of immune interactions that can support the development of multiplex diagnostics, vaccines and therapeutics.

Led by Sequoia, Benchling Raises $200M to Accelerate R&D Cloud Platform

– Today Benchling, the leading life and sciences R&D cloud, announced a $200M Series E raise led by Sequoia Capital Global Equities and joined by Altimeter Capital, Byers Capital, and Elad Gil. This funding will be used to aggressively invest in product development and global expansion to support enterprise customers. The raise is also joined …

Led by Sequoia, Benchling Raises $200M to Accelerate R&D Cloud Platform Read More »

Spark Therapeutics Signs an Option Agreement with Senti Bio to Develop Precision Gene Therapies

Shots: Senti Bio to receive up front and funding to support its research activities. If Spark exercises the option, Senti Bio will be eligible to receive an option exercise payment, development, regulatory, and sales milestone along with royalties per product which may exceed $645M Senti Bio will lead designing, building, and testing cell type and …

Spark Therapeutics Signs an Option Agreement with Senti Bio to Develop Precision Gene Therapies Read More »

Q1 2021 Health IT/Digital Health PC/VE, M&A, IPOs/ SPACs Activity

The first quarter of 2021 has been one of investor optimism as the vaccine rollout continues ahead of expectations and economic activity begins to accelerate in response.  Within the Health IT industry, the already strong investment and M&A trends seen in 2020 have only accelerated.  Over the course of the quarter, we observed $7 billion in private …

Q1 2021 Health IT/Digital Health PC/VE, M&A, IPOs/ SPACs Activity Read More »

Sanofi licences in potential oral IL-17 drug from UK’s C4X Discovery

Sanofi has licensed a potential inflammatory diseases drug from Manchester University spin-off C4X Discovery Holdings in a deal worth up to €414 million ($492 million). While the headline figure looks significant the UK biotech will receive only €7 million up front, reflecting the fact that the drug has not yet begun clinical testing. The rest …

Sanofi licences in potential oral IL-17 drug from UK’s C4X Discovery Read More »

Cancer Research UK spinout Achilles raises $175.5m in IPO

UK biotech Achilles Therapeutics has completed its initial public offering (IPO) in the US, raising $175.5 million that will be used to take its personalised T cell therapy for lung and skin cancers through proof-of-concept trials. The new funding will also be used to advance two more T cell programmes for head and neck and …

Cancer Research UK spinout Achilles raises $175.5m in IPO Read More »

BMS and PsiOxus Therapeutics Expand their 2016 Immuno-Oncology Collaboration

Shots: In the P-I SPICE study, the companies will evaluate the clinical combination of BMS’ Opdivo with PsiOxus’ NG-641 and optimize the combination IV dosing regimen in late-stage cancer patients to treat a range of tumor types PsiOxus will be responsible to conduct P-I study with patient recruitment expected to initiate in Q3’21 NG-641 is …

BMS and PsiOxus Therapeutics Expand their 2016 Immuno-Oncology Collaboration Read More »

Novartis Collaborates with Artios Pharma to Discover Next Generation DDR Cancer Therapies

Shots: Artios to receive $20M upfront in addition to near term research funding to support the collaboration and is eligible to receive $1.3B in discovery, development, regulatory, and sales milestones along with royalties on net sales of products During the 3-yr collaboration, Artios and Novartis will discover and validate up to three exclusive DDR targets …

Novartis Collaborates with Artios Pharma to Discover Next Generation DDR Cancer Therapies Read More »

Progenity Signs an Agreement with Ionis Pharmaceuticals to Evaluate Oral Biotherapeutics Delivery System with Antisense Oligonucleotides

Shots: In the P-I study, the companies will evaluate the OBDS with Ionis’ drug for in vitro compatibility and performance as well as in vivo safety, tolerability, and performance in a preclinical canine model Progenity expects that the alliance could demonstrate the versatility of OBDS in delivering a range of different molecules Ionis’ novel antisense …

Progenity Signs an Agreement with Ionis Pharmaceuticals to Evaluate Oral Biotherapeutics Delivery System with Antisense Oligonucleotides Read More »

9th PREDiCT: Tumor Models Cell Therapy Summit

With high stakes to satisfy unmet patient needs, cell therapy is a promising but challenging field of oncology. There is a crucial need to progress candidates from bench to bedside. With that in mind, I am delighted to share the official agenda and speaker faculty for the 9th PREDiCT: Tumor Models Cell Therapy Summit. Taking place as …

9th PREDiCT: Tumor Models Cell Therapy Summit Read More »

3rd Cell Engager Summit

With that in mind, the 3rd Cell Engager Summit (June 30 – July 1) is the only industry-led meeting focused on developing multi-specific cell engaging therapies in solid tumor indications, and accelerating early discovery innovation into the clinic. With over 32 world-class speakers set to share their ground-breaking insights, this is a learning and networking experience you won’t want to …

3rd Cell Engager Summit Read More »

Ultragenyx Collaborates with n-Lorem Foundation to Advance Personalized Medicines Treatment for Patients with Ultra-Rare Diseases

Shots: The companies collaborated to develop the personalized medicines for patients with ultra-rare diseases. The collaboration involves additional resources, financial contribution, and experience from both the company The alliance strengthens n-Lorem’s mission to bring immediate hope and rapid treatment to ultra-rare disease patients in need n-Lorem Foundation provides a free and lifetime supply of ASO …

Ultragenyx Collaborates with n-Lorem Foundation to Advance Personalized Medicines Treatment for Patients with Ultra-Rare Diseases Read More »

Gilead Expands its Collaboration with AbCellera to Develop Antibodies Against Multiple Indications

Shots: AbCellera to receive upfront, milestone, and royalties based on the development and commercialization of Abs, emerge under the collaboration The expanded collaboration will utilize AbCellera’s technology stack, which includes Trianni Mouse and OrthoMab protein engineering platform AbCellera will generate panels of Abs against up to 8 new targets across multiple indications, selected by Gilead …

Gilead Expands its Collaboration with AbCellera to Develop Antibodies Against Multiple Indications Read More »

Merck KGaA Exercises Third Option in its Immuno-Oncology Collaboration with F- star

Shots: F-star to receive option exercise payment and will be eligible to get milestones and royalties on net sales of therapies resulting from the collaboration Merck KGaA exercises its third option to develop an additional bispecific program under the ongoing collaboration with F-star Merck KGaA will be responsible for the development and commercialization of the …

Merck KGaA Exercises Third Option in its Immuno-Oncology Collaboration with F- star Read More »

Morehouse College, Verily Announces $575k Endowed Life Sciences Scholarship to Support STEM Careers

– Today, Verily announced a partnership with Morehouse College in Atlanta, GA, to establish an endowed award of $575,000 to fund a new Verily Scholars Program.  – The program will provide an annual scholarship to an exceptional Morehouse student majoring in STEM (Science, Technology, Mathematics, and Engineering) careers and will also fund up to three annual all-expenses …

Morehouse College, Verily Announces $575k Endowed Life Sciences Scholarship to Support STEM Careers Read More »

GSK and VIR Report EUA Submission to the US FDA for VIR-7831 to Treat COVID-19

Shots: The EUA submission is based on an interim analysis of the P-III COMET-ICE study assessing VIR-7831 vs PBO for the early treatment of COVID-19 in 583 adults at high risk of hospitalization The study demonstrated an 85% reduction in hospitalization. Due to evidence of profound efficacy, IDMC recommended stopping the trial for further enrollment …

GSK and VIR Report EUA Submission to the US FDA for VIR-7831 to Treat COVID-19 Read More »

Aura raises $80m to develop its virus-like cancer drugs

US biotech Aura Biosciences has closed an oversubscribed financing, raising $80 million to help take its lead virus-like drug conjugate (VDC) for a cancer that affects the eye into late-stage development. The Cambridge, Massachusetts-based company is currently testing belzupacap sarotalocan (AU-011) in a phase 2 trial involving patients with choroidal melanoma, a tumour that develops …

Aura raises $80m to develop its virus-like cancer drugs Read More »

Takeda Collaborates with Evotec on RNA Targeting Drug Development

Shots: Evotec to receive research funding and will be eligible for $160M/program as discovery, pre/ clinical, a commercial milestone along with royalties on sales of product emerges from the collaboration The collaboration will utilize Evotec’s RNA targeting platform to identify RNA sequences to target with small-molecule ligands aligned that can be developed into the first-in-class …

Takeda Collaborates with Evotec on RNA Targeting Drug Development Read More »

Meet our new Chair Deborah Keller

Deborah Keller is a dynamic woman who gives off an immediate sense of warmth and humor. The moment she joined our video chat, she began sharing stories about her life in lockdown, admitting to feeling so cooped up that she painted her laundry room at 9 pm the night before. However, underneath her easy-going exterior …

Meet our new Chair Deborah Keller Read More »

Meet our new Chair Deborah Keller

Deborah Keller is a dynamic woman who gives off an immediate sense of warmth and humor. The moment she joined our video chat, she began sharing stories about her life in lockdown, admitting to feeling so cooped up that she painted her laundry room at 9 pm the night before. However, underneath her easy-going exterior …

Meet our new Chair Deborah Keller Read More »

Takeda Collaborates with Anima to Discover and Develop mRNA Translation Modulators for Neurological Diseases

Shots: Anima to receive ~ $120M up front, preclinical milestones and ~$1.1B as clinical and commercial milestones along with royalties on each product emerge under the collaboration Takeda gets an exclusive right to develop and commercialize the mRNA transational modulators and has a time limited option to expands the collaboration for three additional targets for …

Takeda Collaborates with Anima to Discover and Develop mRNA Translation Modulators for Neurological Diseases Read More »

Takeda Collaborates with Anima to Discover and Develop mRNA Translation Modulators for Neurological Diseases

Shots: Anima to receive ~ $120M up front, preclinical milestones and ~$1.1B as clinical and commercial milestones along with royalties on each product emerge under the collaboration Takeda gets an exclusive right to develop and commercialize the mRNA transational modulators and has a time limited option to expands the collaboration for three additional targets for …

Takeda Collaborates with Anima to Discover and Develop mRNA Translation Modulators for Neurological Diseases Read More »

Pfizer Signs a WW License Agreement with Pyxis to Develop and Commercialize Two ADC Candidates

Shots: Pfizer to receive an up front, equity in Pyxis and is eligible for development & commercial milestones as well as royalties on potential sales of ADCs Pyxis gets a WW license to develop and commercialize PYX-201 and PYX-203. Pfizer will continue to support the development and advancement of ADCs portfolio via an equity investment …

Pfizer Signs a WW License Agreement with Pyxis to Develop and Commercialize Two ADC Candidates Read More »

Pfizer Signs a WW License Agreement with Pyxis to Develop and Commercialize Two ADC Candidates

Shots: Pfizer to receive an up front, equity in Pyxis and is eligible for development & commercial milestones as well as royalties on potential sales of ADCs Pyxis gets a WW license to develop and commercialize PYX-201 and PYX-203. Pfizer will continue to support the development and advancement of ADCs portfolio via an equity investment …

Pfizer Signs a WW License Agreement with Pyxis to Develop and Commercialize Two ADC Candidates Read More »

Takeda Signs a License Agreement with Genevant to Develop Novel Nucleic Acid Therapeutics for Liver Fibrosis

Shots: Genevant to receive up to $600M up front and milestone as well as royalties on future product sales Takeda get exclusive rights to access Genevant’s LNP technology for a specified number of selected hepatic stellate cells targets The companies collaborated to discover, develop and commercialize the LNP-delivered nucleic acid therapeutics directed to previously inaccessible …

Takeda Signs a License Agreement with Genevant to Develop Novel Nucleic Acid Therapeutics for Liver Fibrosis Read More »

PhaseBio Signs a Supply Agreement with BioVectra to Support the Development and Commercialization of Bentracimab

Shots: BioVectra to provide its integrated CDMO services for the manufacturing of API of bentracimab for use in PhaseBio’s ongoing global studies and global commercial use upon regulatory approval PhaseBio plans to integrate API manufactured at a commercial scale at BioVectra into the ongoing P-IIb and P-III REVERSE-IT study to support the global regulatory filings …

PhaseBio Signs a Supply Agreement with BioVectra to Support the Development and Commercialization of Bentracimab Read More »

SMA Foundation Collaborates with PTC to Discover and Develop Regenerative Medicine

Shots: SMA Foundation and PTC will provide an initial investment of up to $60M in research to discover & develop regenerative treatments in neuromuscular diseases The focus of the agreement is advance scientific research in SMA and other neuromuscular disorders to develop new treatments The availability of several disease-modifying therapies has made regenerative interventions the …

SMA Foundation Collaborates with PTC to Discover and Develop Regenerative Medicine Read More »

Sorrento Collaborates with Mount Sinai to Develop Ab Combination for Neutralizing SARS-CoV-2 and other Emerging Variants of COVID-19

Shots: The companies signed an exclusive license agreement to develop COVISHIELD + two mAb cocktail against emerging variants of SARS-CoV-2 including UK (B.1.1.7), South Africa (B.1.351), and Japan/Brazil (B.1.128) variants The pre-clinical development of Ab combination (IV and intranasal) including Sorrento and Mount Sinai Abs is underway The collaboration follows Sorrento’s efforts to eradicate COVID-19 …

Sorrento Collaborates with Mount Sinai to Develop Ab Combination for Neutralizing SARS-CoV-2 and other Emerging Variants of COVID-19 Read More »

Exelixis Signs an Exclusive License Agreement with WuXi Biologics to Expand its Growing Oncology Biologics Pipeline

Shots: WuXi Bio to receive up front and is eligible for development & commercialization milestones, along with royalties on sales of any potential products commercialized from the panel Exelixis get an exclusive license to the panel of mAb against an undisclosed oncology target for biologics applications Exelixis leverages WuXi Bio’s integrated technology platforms to develop …

Exelixis Signs an Exclusive License Agreement with WuXi Biologics to Expand its Growing Oncology Biologics Pipeline Read More »

Lilly Collaborates with Biolojic to Discover and Develop Antibody Therapies for Diabetes

Shots: Biolojic to receive ~$121M including development and commercialization milestones and a promissory note that may be convertible into Biolojic equity in future Additionally, Biolojic is eligible to receive royalties on sales of therapies that emerges during the collaboration The collaboration will leverage Biolojic’s AI-based multibody platform to discover and develop a potential novel Ab-based …

Lilly Collaborates with Biolojic to Discover and Develop Antibody Therapies for Diabetes Read More »

bene : studio Launches HealthTech Product Accelerator Starting April 1st

What You Should Know: – bene : studio, a San Francisco, CA-based global digital product consultancy, announced its non-equity, online HealthTech Product Accelerator, starting on April 1st. The accelerator will focus exclusively on the enhancement of the participating companies’ design and technology. – This accelerator is tailored to advanced Health Tech startups with $1M+ yearly …

bene : studio Launches HealthTech Product Accelerator Starting April 1st Read More »

UK chancellor Sunak urged to boost pharma and biotech in budget

UK chancellor Rishi Sunak has been urged to recognise the leading role that pharma companies are playing in the economy in this week’s budget. Sunak is due to make his closely-watched budget speech tomorrow (Wednesday) in the House of Commons, starting from about 12.30. The Conservative Party has strong ties with pharma and life sciences …

UK chancellor Sunak urged to boost pharma and biotech in budget Read More »

More healthcare startups go public through SPACs — but will they succeed?

More healthcare startups are choosing to go public through mergers with special-purpose acquisition companies— publicly-traded shell companies created with the purpose of taking a private company public. But as more SPACs search for targets, and company valuations grow, will the SPAC bubble burst?

Sanofi Collaborates with Sirion to Develop Gene Therapy Treatment with Improved AAV Capsids

Shots: The companies collaborated to develop improved tissue-selective AAV vectors to realize effective gene therapy treatments for multiple life-threatening disorders The focus of this agreement is to develop new and modified AAV capsids that exhibit a safe product profile with improved specificity and higher gene delivery efficiency The collaboration comes two years after Sirion signed …

Sanofi Collaborates with Sirion to Develop Gene Therapy Treatment with Improved AAV Capsids Read More »

UCB Collaborates with Microsoft to Accelerate Drug Discovery and Development

Shots: The collaboration will merge Microsoft’s computational services, cloud and AI with UCB’s drug discovery and development capabilities The companies intend to discover and develop medicines for people living with severe diseases in immunology and neurology. The collaboration follows UCB and Microsoft’s collaboration around COVID-19 Microsoft will provide AI technology and applied scientists to work …

UCB Collaborates with Microsoft to Accelerate Drug Discovery and Development Read More »

Bio-Techne Collaborates with Luminary to Utilize TcBuster in the Development of CAR-T cell Therapies

Shots: The companies signed a license agreement to deploy TcBuster for the manufacturing of gene-modified cell therapies Luminary gets a non-exclusive license for TcBuster and will use it in the LMY-920 program. Luminary plans to file an IND with the FDA in late 2021 The license agreement will allow Bio-Techne to increase its presence in …

Bio-Techne Collaborates with Luminary to Utilize TcBuster in the Development of CAR-T cell Therapies Read More »

Roche Concludes the License Agreement with Chugai for AT-527 to Treat COVID-19 in Japan

Shots: Chugai gets exclusive development and commercializing rights for AT-527 in Japan Earlier, Roche and Atea collaborated to jointly develop AT-527. If approved, Atea to distribute AT-527 in the US and Roche will be responsible for global manufacturing and distribution outside the US AT-527 is an investigational, oral, purine nucleotide prodrug, currently being evaluated in …

Roche Concludes the License Agreement with Chugai for AT-527 to Treat COVID-19 in Japan Read More »

Could CRISPR cure HIV? US biotech Excision raises $60m to find out

US biotech Excision BioTherapeutics has raised $60 million to test a potential HIV cure in the clinic, which would use CRISPR technology to snip out the viral code from human cells and tissues. Once someone is infected with HIV it stays with them for life thanks to the retrovirus’s ability to inject its DNA code …

Could CRISPR cure HIV? US biotech Excision raises $60m to find out Read More »

GSK Expand its 2020 Collaboration with Vir to Advance New Therapies for Influenza and Other Respiratory Viruses

Shots: Vir will receive ~$225M up front, $120M as an equity investment and $200M as regulatory milestones, ~300M as option payment and will be responsible to fund the development of VIR-2482 through the completion of the P-II trial GSK to get an exclusive option to co-develop VIR-2482 after Vir completes and reports P-II trial outcomes, …

GSK Expand its 2020 Collaboration with Vir to Advance New Therapies for Influenza and Other Respiratory Viruses Read More »

Novartis Collaborates with Bill & Melinda Gates Foundation to Discover and Develop Gene Therapy for Sickle Cell Disease

Shots: The Gates Foundation will provide funding support to discover and develop in vivo gene therapy for SCD. The alliance brings together Novartis drug discovery and gene therapy expertise with Gates’ funding’s The focus of the agreement to address the disparity in access to treatments and to prioritize populations and regions bearing the greatest burden …

Novartis Collaborates with Bill & Melinda Gates Foundation to Discover and Develop Gene Therapy for Sickle Cell Disease Read More »

Novartis Report Results of Kesimpta (ofatumumab) Sensoready autoinjector pen for Multiple Sclerosis

Shots: The multicenter survey involves assessing Kesimpta Sensoready autoinjector pen in 80 MS patients and 50 MS nurses, with RMS who received a disease modifying treatment through a subcutaneous/intramuscular injection via an autoinjector The result shows MS patients and nurses prefer the Kesimpta Sensoready autoinjector pen over other autoinjectors for current treatment (84% vs 16%). …

Novartis Report Results of Kesimpta (ofatumumab) Sensoready autoinjector pen for Multiple Sclerosis Read More »

Guardant Health Launches Guardant Reveal Liquid Biopsy Test for Early-Stage Colorectal Cancer

Shots: The company has launched Guardant Reveal liquid biopsy test for the detection of residual and recurrent disease from a simple blood draw to monitor CRC patients with 7-day turnaround time, residual disease after surgery and recurrence mos. earlier than current SoC methods like CEA tests or imaging The test can deliver industry leading sensitivity …

Guardant Health Launches Guardant Reveal Liquid Biopsy Test for Early-Stage Colorectal Cancer Read More »

Mega biotech Centessa beams up ex-Warp Speed science chief Slaoui

Operation Warp Speed’s former science chief Moncef Slaoui is to lead research at a new mega-biotech called Centessa, formed by the merger of 10 privately-held life science startups. President Joe Biden asked Slaoui to step down as chief scientific adviser to the US COVID-19 vaccine initiative after the White House administration changed late last month …

Mega biotech Centessa beams up ex-Warp Speed science chief Slaoui Read More »

Aker BioMarine Collaborate with Université de Sherbrooke Department of Medicine for Alzheimer’s Disease

Shots: The alliance will investigate the effectiveness of LPC-bound EPA/DHA in preventing cognitive decline linked to AD. Aker BioMarine will supply the research team with its krill-based LPC EPA/DHA product (Lysoveta) The team will evaluate the link between genetic variations in lipid metabolism & transport of EPA/DHA across the BBB using knock-in mice for human …

Aker BioMarine Collaborate with Université de Sherbrooke Department of Medicine for Alzheimer’s Disease Read More »

Disgraced biotech investor Woodford plans revival as UK biotech booms

Disgraced investor Neil Woodford plans to start a new biotech investment firm as he seeks to capitalise on a booming UK life sciences industry and rebuild his reputation following the collapse of his previous fund. According to press reports, Woodford will be chief investment officer of Woodford Capital Management. The news was first reported by …

Disgraced biotech investor Woodford plans revival as UK biotech booms Read More »

Takeda Collaborates with Ensoma to Accelerate Next-Generation In Vivo Gene Therapies

Shots: Ensoma to receive $100M in up front & preclinical research payment, $10M in equity investment, and is eligible to receive $1.25B as development and commercialization milestones along with royalties on sales of each product Takeda to get an exclusive WW rights Ensoma’s Engenious vectors for up to five rare disease indications. Ensoma to conduct …

Takeda Collaborates with Ensoma to Accelerate Next-Generation In Vivo Gene Therapies Read More »

BMS Collaborate with Molecular Templates to Develop Engineered Toxin Body Therapies for Cancer

Shots: MTEM to receive $70M up front and is also eligible to receive ~$1.3B as development, regulatory and sales milestone along with royalties on future sales MTEM will be responsible for research activities to discover next generation ETBs for multiple targets, of which BMS selected the first target. BMS to get an option to obtain …

BMS Collaborate with Molecular Templates to Develop Engineered Toxin Body Therapies for Cancer Read More »

Sanofi Collaborates with i2O Therapeutics to Evaluate Oral i2O Therapeutics

Shots: The companies collaborated to investigate oral delivery of Sanofi’s Nanobody based medicines, which are currently available in IV & SC formulations The collaboration will advance the formulation of therapies that are traditionally limited to injections. Nanobodies are the therapeutic proteins based on camelid-derived immunoglobulin single variable domains & have potential to treat multiple diseases …

Sanofi Collaborates with i2O Therapeutics to Evaluate Oral i2O Therapeutics Read More »

AbbVie Signs a License Agreement with Caribou Biosciences for CAR-T Cell Therapies

Shots: Caribou to receive $40M up front in cash & equity investment, ~$300M in development, regulatory, and launch milestones along with additional commercial milestones and global royalties AbbVie will utilize and gets exclusive rights to Caribou’s next-generation Cas12a chRDNA genome editing and cell therapy technologies to develop two new CAR-T cell therapies directed to specified …

AbbVie Signs a License Agreement with Caribou Biosciences for CAR-T Cell Therapies Read More »

CureVac Collaborate with UK Government to Develop Vaccines Against SARS-CoV-2 variants

Shots: The collaboration combines expertise, resources and technology from both parties to develop and manufacture variant vaccines against SARS-CoV-2 variants. CureVac is expected to supply 50M doses of variant vaccines to the UK, following the regulatory approval The VTF and the CureVac will deploy mRNA platform to assess multiple SARS-CoV-2 variants and are expected to …

CureVac Collaborate with UK Government to Develop Vaccines Against SARS-CoV-2 variants Read More »

Thermo Fisher Collaborates with JW Therapeutics for CAR-T Therapies in China

Shots: The companies signed an agreement to ensure non-exclusive commercial access to Thermo Fisher’s Gibco CTS Dynabeads CD3/CD28 The focus of the agreement is to support clinical development & commercial manufacturing of leading CAR-T therapies in China including JW’s relmacabtagene autoleucel (relma-cel) Relma-cel is an anti-CD19 CAR-T therapy for 3L treatment for r/r B-cell lymphoma …

Thermo Fisher Collaborates with JW Therapeutics for CAR-T Therapies in China Read More »

GSK Collaborate with CureVac to Develop Next Generation mRNA COVID-19 Vaccines

Shots: CureVac to receive $90.14M up front, $90.14M as milestones on the achievement of specific milestones. GSK will be the marketing authorization holder for the vaccine (Ex-Switzerland) and will have exclusive rights in all countries except Germany, Austria and Switzerland Additionally, GSK will support the manufacture of ~100M doses of CureVac’s first generation COVID-19 vaccine …

GSK Collaborate with CureVac to Develop Next Generation mRNA COVID-19 Vaccines Read More »

Gilead Signs an Option and License Agreement with Gritstone for HIV Vaccine

Shots: Gristone to receive $60M at closing, including $30M up front and a $30M as an equity investment at a premium and is eligible to receive up to ~$725M as option exercise payments and milestones along with royalties on sales of therapy Gilead will be in charge of conducting a P- I study for the …

Gilead Signs an Option and License Agreement with Gritstone for HIV Vaccine Read More »

Merck Signs an Exclusive Worldwide License Agreement with Artiva to Develop CAR-NK Cell Therapies

Shots: Artiva to receive $30M up front for the first 2 programs & an additional $15M, if Merck exercises its option for a third program. Artiva to get ~$612M/ program as development & commercial milestones and royalties on the global sales of the product emerge from the collaboration Artiva receives funding from Merck for each …

Merck Signs an Exclusive Worldwide License Agreement with Artiva to Develop CAR-NK Cell Therapies Read More »

AstraZeneca Selects AI-Generated CKD Target Under its Collaboration with BenevolentAI

Shots: AstraZeneca has selected a novel CKD target to advance to its drug development portfolio, making it the first AI-generated target from the collaboration to enter its portfolio In 2019, companies collaborated to discover new drugs for CKD and IPF The collaboration leverages AstraZeneca’s scientific expertise and rich datasets with BenevolentAI’s target identification platform to …

AstraZeneca Selects AI-Generated CKD Target Under its Collaboration with BenevolentAI Read More »

MTPA and Aquestive Sign a License and Supply Agreement for Exservan (riluzole) to Treat ALS in the US

Shots: Aquestive will receive upfront, milestones, royalties on net sales for Exservan (oral film formulation) in the US and will earn revenue pursuant to the exclusive supply agreement MTPA to commercialize Exservan in the US while Aquestive will serve as the exclusive sole manufacturer and supplier for the product Exservan is an oral film formulation …

MTPA and Aquestive Sign a License and Supply Agreement for Exservan (riluzole) to Treat ALS in the US Read More »

Servier and MiNA Therapeutics Collaborate to Develop saRNA Therapies for Neurological Diseases

Shots: MiNA to receive $267.6M in up front, exclusivity fee on first neurological target and will be eligible to receive research, development, regulatory and commercial milestones along with royalties Servier will lead pre/ clinical development of lead candidates and will have the rights to commercialize any products that emerges from the collaboration The collaboration integrates …

Servier and MiNA Therapeutics Collaborate to Develop saRNA Therapies for Neurological Diseases Read More »

Bio Integrates 2021 (Digital)

Making new connections is vital to helping the biotech industry continue their journey. Bio Integrates creates these opportunities and provides attendees with significant opportunities to learn from and interact with our growing community, to enhance both current and future needs. Our debate-led format provides our attendees with the opportunity to hear from and ask questions …

Bio Integrates 2021 (Digital) Read More »

Prescient Healthcare Group to Partner with Bridgepoint Development Capital

The partnership will further enhance the depth, breadth and value of services for Prescient’s pharmaceutical and biotech clients. LONDON, January 21, 2021: Prescient Healthcare Group (Prescient), a global product strategy advisory firm serving the pharmaceutical and biotech industries, announced today that Bridgepoint Development Capital, part of Bridgepoint, the international alternative asset management group, has agreed …

Prescient Healthcare Group to Partner with Bridgepoint Development Capital Read More »

Lilly and Merus Collaborate to Discover Novel T-Cell Re-Directing Bispecific Antibodies

Shots: Merus to receive $40M up front, $20M as an equity investment, ~$540M as development & commercial milestones making it a total of $1.6B for three products, along with royalties, following the commercialization of therapies Merus will lead discovery and early-stage research activities while Loxo Oncology at Lilly will be responsible for additional research, development, …

Lilly and Merus Collaborate to Discover Novel T-Cell Re-Directing Bispecific Antibodies Read More »

Janssen Signs a Research Agreement with TenNor to Develop Treatments for Nontuberculous Mycobacteria Diseases

Shots: The companies plan to leverage TenNor’s multitargeting drug conjugation platform to discover new therapies for NTM diseases. The agreement was facilitated by J&J The focus of the pact to discover and develop novel therapies for NTM diseases with the potential to shorten the duration of treatment with better safety and efficacy The collaboration builds …

Janssen Signs a Research Agreement with TenNor to Develop Treatments for Nontuberculous Mycobacteria Diseases Read More »

Boehringer Ingelheim Collaborates with Cure Genetics to Develop Next-Generation Liver-Targeted Gene Therapy

Shots: The companies collaborated to develop AAV vectors deploying Cure Genetics’ VELP platform to develop next-generation gene therapies The focus of the pact is to provide new AAV serotypes for patients. The collaboration integrates Boehringer Ingelheim’s experience in disease biology and gene therapy development with Cure Genetics’ AAV expertise in library construction and in vivo …

Boehringer Ingelheim Collaborates with Cure Genetics to Develop Next-Generation Liver-Targeted Gene Therapy Read More »

Cerner Leadership Changes, Other Key Executives Hires

Travis Dalton Dan Devers Cerner announced some leadership changes promoting long-time associates Travis Dalton to Chief Client & Services Officer and Dan Devers to Chief Legal Counsel. After long, respected, meaningful careers at Cerner, John Peterzalek and Randy Sims will be departing. Cognoa, the leading pediatric behavioral health company developing diagnostic and therapeutic solutions for children living with …

Cerner Leadership Changes, Other Key Executives Hires Read More »

Takeda and KSQ Collaborate to Develop and Commercialize Novel Immuno-Oncology Therapies

Shots: KSQ to receive $100M+ as up front and preclinical milestones and up to $400M+/ program in option payment and development & commercialization milestones along with royalties on sales of each approved products The deal includes two KSQ’s previously identified & validated T-cell targets with the potential to introduce two additional targets to the collaboration …

Takeda and KSQ Collaborate to Develop and Commercialize Novel Immuno-Oncology Therapies Read More »

Sanofi Signs a License Agreement with Biond for BND-22

Shots: Biond to receive $125M up front in cash and will be eligible to receive ~$1B+ as development, regulatory & commercial milestones, along with royalties on sales of the therapy Biond will lead P-Ia study of BND-22, assessing its safety & tolerability as a single agent and in combination with approved cancer therapies as well …

Sanofi Signs a License Agreement with Biond for BND-22 Read More »

AstraZeneca Collaborates with Adaptive on Mapping Immune Response in Cancer

Shots: The companies collaborated to evaluate the use of immunoSEQ T-MAP, for which Adaptive will receive quarterly payments + sequencing and data mapping fees AstraZeneca to provide cancer patients’ biological samples while Adaptive will sequence the samples & deliver TCR-antigen mapping data using its clinical immunomics database of 58B+ immune cell receptors and antigens AstraZeneca …

AstraZeneca Collaborates with Adaptive on Mapping Immune Response in Cancer Read More »

Novartis In-Licenses BieGene’s Tislelizumab to Expand its Oncology Portfolio

Shots: BieGene to receive $650M as up front along with milestones and royalties and will retain rights to Tislelizumab in China and other countries Novartis to get the development & commercialization rights to tislelizumab in the US, Canada, Mexico, EU, UK, Norway, Switzerland, Iceland, Liechtenstein, Russia, & Japan. Additionally, the companies have identified multiple tislelizumab …

Novartis In-Licenses BieGene’s Tislelizumab to Expand its Oncology Portfolio Read More »

Almirall and Tyris Collaborate to Develop Next Generation Gene Therapies

Shots: Tyris to receive up front, research milestone along with research funding and will be responsible for generating clinical lead candidates and will further progress them to clinical development Almirall to get an exclusive option to acquire gene therapies and progress them through clinical development to commercialization The collaboration will integrate Tyris’s non-viral based gene …

Almirall and Tyris Collaborate to Develop Next Generation Gene Therapies Read More »

Bayer Collaborates with CureVac for CVnCoV Against COVID-19

Shots: Bayer to support the development, supply and key territory operations of CureVac´s COVID-19 vaccine candidate, CVnCoV and will contribute its expertise and established infrastructure in numerous area Curevac will be the MAH for the product while Bayer will support CureVac with country operations within the EU and additional markets. Additionally, Bayer has an option …

Bayer Collaborates with CureVac for CVnCoV Against COVID-19 Read More »

Pfizer Signs a License and Supply Agreement with ImaginAb for CD8 ImmunoPET Technology

Shots: ImaginAb to receive license fees and payments for manufacturing and other support and will supply clinical doses of 89Zr CD8 Immuno-PET agent to Pfizer for use in select oncology clinical trials ImaginAb will provide technical, clinical & regulatory support to Pfizer The collaboration follows the pre-competitive alliance b/w ImaginAb, Pfizer and other global companies …

Pfizer Signs a License and Supply Agreement with ImaginAb for CD8 ImmunoPET Technology Read More »

Genentech Signs ~$1B Pact with Ribometrix to Develop RNA-Targeted Small Molecule Therapies

Shots: Ribometrix to receive $25M up front, ~$1B+ as milestones along with royalties on sales of therapies emerges from the collaboration The companies collaborated on the discovery & preclinical development of programs. Genentech will lead further development and commercialization and will have exclusive rights to several predefined targets including an exclusive global license for the …

Genentech Signs ~$1B Pact with Ribometrix to Develop RNA-Targeted Small Molecule Therapies Read More »

AbbVie Reports Results of Skyrizi (Risankizumab) in P-III Studies for Active Psoriatic Arthritis

Shots: The two P-III studies KEEPsAKE-1 & -2 involves assessing Skyrizi (150mg) vs PBO followed by risankizumab (150mg, @24wks.) in patients with active PsA who had an inadequate response or intolerant to at least one biologic therapy and/or non-biologic DMARDs respectively Results: ACR20 (57% & 51% vs 34% & 27%); ACR50 (33% & 26% vs …

AbbVie Reports Results of Skyrizi (Risankizumab) in P-III Studies for Active Psoriatic Arthritis Read More »

Biogen Signs a License Agreement with ViGeneron for Ophthalmic Gene Therapy Development

Shots: ViGeneron to receive an up front and R&D funding for the mutually agreed workplan and will receive development, regulatory and commercial milestone payments along with royalties on sales of products arising from the collaborations ViGeneron will optimize and validate in vitro therapeutic candidates for undisclosed target to treat inherited eye disease while Biogen has …

Biogen Signs a License Agreement with ViGeneron for Ophthalmic Gene Therapy Development Read More »

Amazon, AstraZeneca, Pfizer, Merck to Build $10M Digital Health Innovation Lab in Israel

Rehovot Science Park What You Should Know: – Pfizer, AstraZeneca, Merck, and Teva, and Amazon Web Services (AWS) has been selected by the Israel Innovation Authority to establish an innovation lab in the fields of digital health and computational biology. – The innovation lab located in the Rehovot Science Park will receive a government budget …

Amazon, AstraZeneca, Pfizer, Merck to Build $10M Digital Health Innovation Lab in Israel Read More »

Pfizer Report the US FDA’s Acceptance and Priority Review of sNDA for Lorbrena (lorlatinib) to treat (ALK)-Positive (NSCLC)

Shots: The US FDA has accepted for Priority Review the sNDA is based on the pivotal CROWN study and is being reviewed by the FDA under its Real-Time Oncology Review (RTOR) CROWN is P-lll, parallel 2-arm trial in which 296 previously untreated advanced ALK-positive NSCLC were randomized in ratio 1:1 to receive LORBRENA monotherapy (n=149) …

Pfizer Report the US FDA’s Acceptance and Priority Review of sNDA for Lorbrena (lorlatinib) to treat (ALK)-Positive (NSCLC) Read More »

Merck Signs a ~$1B Pact with Janux to Develop Cancer Therapies Using T Cell Engager Technology

Shots: Janux to receive up to $500.5M/ target as upfront and milestones along with royalties on sales of product emerges from the collaboration, making a total deal value ~$1B. Merck will fund R&D performed under the agreement Merck to get an exclusive WW license to products & IP developed from the collaboration The focus of …

Merck Signs a ~$1B Pact with Janux to Develop Cancer Therapies Using T Cell Engager Technology Read More »

Minervax raises €47.4m in Series B funding round for GBS shot

Denmark’s MinervaX has raised €47.4 million (around $56 million) in a Series B funding round to take its novel group B streptococcus (GBS) vaccine into mid-stage clinical trials. When and if the pandemic finally recedes there will still be an ongoing issue with a dearth of new antibiotics and a growing number of bacterial strains …

Minervax raises €47.4m in Series B funding round for GBS shot Read More »

Genentech’s Ocrevus Shorter 2-Hour Infusion Receives the US FDA’s Approval for Relapsing & Primary Progressive Multiple Sclerosis

Shots: The approval is based on ENSEMBLE PLUS study, which demonstrated similar frequency and severity of IRRs for 2hrs. Ocrevus infusion time vs conventional 3.5hrs in patients with RRMS. The initial dose is given as two 300mg infusions given 2wks. apart and a subsequent dose of single 600mg infusions were administered over a shorter, 2hrs. …

Genentech’s Ocrevus Shorter 2-Hour Infusion Receives the US FDA’s Approval for Relapsing & Primary Progressive Multiple Sclerosis Read More »

Chugai In-Licenses Roche’s Antibody Cocktail for COVID-19 in Japan

Shots: Chugai get an exclusive development and commercialization agreement in Japan for Roche’s Ab cocktail of casirivimab and imdevimab to combat COVID-19 Earlier, Roche & Regeneron collaborated for the development & commercialization of Ab cocktail where Regeneron will distribute the treatment in the US while Roche will be lead manufacturing and distribution activities outside the …

Chugai In-Licenses Roche’s Antibody Cocktail for COVID-19 in Japan Read More »

Astellas Collaborates with KaliVir to Develop and Commercialize VET2-L2

Shots: KaliVir to receive $56M as upfront & other payments supporting the research & preclinical activities of VET2-L2 & is eligible to receive $307M & $271M as development, regulatory & commercialization for VET2-L2 & second product, respectively along with royalties on sales of each licensed product The alliance integrates KaliVir’s expertise in the development of …

Astellas Collaborates with KaliVir to Develop and Commercialize VET2-L2 Read More »

Janssen Reports BLA Submission of Amivantamab to the US FDA for Metastatic NSCLC with EGFR Exon 20 Insertion Mutations

Shots: The BLA is based on the P-I CHRYSALIS study assessing amivantamab as a monothx. and in combination with lazertinib in adult patients with advanced NSCLC The company has established an EAP for patients in the US who may be eligible to obtain access to mivantamab during the review of the BLA Amivantamab is an …

Janssen Reports BLA Submission of Amivantamab to the US FDA for Metastatic NSCLC with EGFR Exon 20 Insertion Mutations Read More »

Merck KGaA Collaborates with Artios Pharma for DNA Damage Cancer Therapies

Shots: Artios to receive $30M up front & near-term milestones, ~$860M/ target as option fee along with royalties on sales of each commercialized product. Additionally, Artios has opt-in rights for joint development & commercialization of the programs Merck has the right to opt into exclusive development & commercialization of compounds on up to 8 targets …

Merck KGaA Collaborates with Artios Pharma for DNA Damage Cancer Therapies Read More »

Swiss start-up Noema raises $59m to develop neurology drugs offloaded by Roche

Swiss biotech Noema has raised 54 million Swiss francs ($59m) to develop four neurological disorder drugs licensed in from Roche. The company is developing four phase 2 drugs brought in from Roche after the big Swiss pharma decided somebody else should take the risk of developing them. Roche, which decided the products were surplus to …

Swiss start-up Noema raises $59m to develop neurology drugs offloaded by Roche Read More »

Regeneron Collaborates with Penn to Explore Intranasal Delivery of COVID-19 Ab Cocktail via Gene Therapy Platform

Shots: Penn allied with Regeneron to investigate Ab cocktail (casirivimab & imdevimab) to prevent COVID-19 infection when delivering intranasally via AAV vectors The collaboration b/w Wilson and Penn’s GTP and Regeneron will have two phases. The first phase will include the validation of the effectiveness of Abs delivered via AAV in a large animal model …

Regeneron Collaborates with Penn to Explore Intranasal Delivery of COVID-19 Ab Cocktail via Gene Therapy Platform Read More »

Moderna Amends its Agreement with UK Government for an Additional 2M Doses of COVID-19 Vaccine

Shots: Moderna amended its current supply agreement with the UK govt. for an additional 2M doses of mRNA-1273 against COVID-19. The UK govt. has now secured 7M doses of mRNA-1273 The agreement reflects Moderna’s commitment to making its vaccine available in multiple countries. Moderna ramp up its global manufacturing to be able to deliver ~500M …

Moderna Amends its Agreement with UK Government for an Additional 2M Doses of COVID-19 Vaccine Read More »

Online Live Team Pharma Forecasting Training Now Available

Working remotely can have its challenges, why not get together for a fun and rewarding learning experience and refresh your forecasting skills? Following the success of J+D Forecasting’s face to face training, the content has been redesigned to make it suitable for live, online audiences.  There are two types of courses, type one is tailored …

Online Live Team Pharma Forecasting Training Now Available Read More »

Egle Identifies First Novel Regulatory T-cell Targets Under its Collaboration with Takeda

Shots: Egle has achieved the first milestone in its research agreement with Takeda, signed in June’2020. Egle will validate novel tumor-infiltrating regulatory T-cell targets while Takeda will develop the potential therapies Egle has leveraged its unique bioinformatic & translational capabilities to identify targets Following the achievement of the target identification, Egle will receive an R&D …

Egle Identifies First Novel Regulatory T-cell Targets Under its Collaboration with Takeda Read More »

Russia’s Sputnik V Demonstrates 91.4% Efficacy Against COVID-19

Shots: The ongoing P-lll study involves assessing of Sputnik V vaccine vs PBO in 40,000 patients in a ratio (1:3) with COVID-19. The efficacy of the vaccine is 91.4%, based on the second interim analysis of data obtained 28 days after administering the first dose Preliminary data from volunteers obtained 42days after the first dose …

Russia’s Sputnik V Demonstrates 91.4% Efficacy Against COVID-19 Read More »

Catamaran joins the CAR-NK fleet, raising $42m in first round

Catamaran Bio has weighed anchor with a $42 million first-round financing that will be used to pull its off-the-shelf natural killer (NK) cell therapies for cancer through early-stage development. The Cambridge, Massachusetts-based biotech is the latest player in the emerging field of chimeric antigen receptor (CAR) NK cell therapies, which unlike the current generation of …

Catamaran joins the CAR-NK fleet, raising $42m in first round Read More »

Eli Lilly Signs an Exclusive Agreement with Precision BioSciences on Genome Editing Research

Shots: Precision to receive $100M upfront, $35M as an equity investment and will receive $420M as milestones/ product along with royalties on sales of licensed products emerges from the collaboration Precision will lead to pre-clinical research and IND-enabling activities while Lilly will lead clinical development and commercialization and have the right to select up to …

Eli Lilly Signs an Exclusive Agreement with Precision BioSciences on Genome Editing Research Read More »

Novartis Signs a License Agreement with Mesoblast to Develop and Commercialize Remestemcel-L for ARDS

Shots: Mesoblast to receive $25M up front and $25M as equity investment with additional payments and royalties on achievement of development, regulatory and commercial milestones Novartis to acquire the exclusive WW rights to develop, commercialize & manufacture remestemcel-L for ARDS & access to a cell-therapy based platform with WW rights to a range of potential …

Novartis Signs a License Agreement with Mesoblast to Develop and Commercialize Remestemcel-L for ARDS Read More »

VC firm SR One completes GSK spin-out, raising $500m

Trans-Atlantic biotech venture capital firm SR One has completed its spin-out from GlaxoSmithKline and closed its first fund with $500m in its coffers. The VC built itself a considerable reputation after it was founded in 1985 and works with entrepreneurs and scientists to build biotechnology companies. GSK is the largest investor in the independent fund, …

VC firm SR One completes GSK spin-out, raising $500m Read More »

Sanofi’s Supemtek (quadrivalent recombinant influenza vaccine) Receives the EC’s Approval to Prevent Influenza

Shots: The approval is based on two P-III studies assessing the safety and efficacy of Supemtek (quadrivalent recombinant influenza vaccine) in 10,000 patients with influenza aged > 18yrs. Supemtek is 1st and only recombinant influenza vaccine approved in the EU The P-III efficacy study demonstrated improved protection against influenza compared to standard-dose influenza vaccine and …

Sanofi’s Supemtek (quadrivalent recombinant influenza vaccine) Receives the EC’s Approval to Prevent Influenza Read More »

TGFB for Immuno-Oncology Drug Development Summit

Are you interested in finding the next breakthrough in immuno-oncology preclinical or clinical development? Recent scientific, clinical breakthroughs and high-profile industry deals have reignited the race to find the next blockbuster TGF-ß inhibitor for immuno-oncology applications. As such, the TGFß for Immuno-Oncology Drug Development Summit (January 26-28) is the ONLY industry-focused meeting dedicated to pharma, biotech, and academia who …

TGFB for Immuno-Oncology Drug Development Summit Read More »

J&J and US Government Amends their Agreement for the Next Phase of COVID-19 Vaccine Development

Shots: J&J and the US Department of Health and Human Services have expanded an agreement to support the next phase of COVID-19 vaccine candidate research and development Janssen will commit ~$604M while BARDA will commit ~$454M to support the ongoing P-lll ENSEMBLE study assessing Janssen’s JNJ-78436735 as a single-dose in ~60,000 patients globally J&J affirmed …

J&J and US Government Amends their Agreement for the Next Phase of COVID-19 Vaccine Development Read More »

Novavax Collaborates with Commonwealth of Australia to Supply 40M doses of NVX-CoV2373 for COVID-19

Shots: Novavax has signed a non-binding Heads of Terms document with the Australian Government to supply 40M doses of NVX-CoV2373 for the Australian community The delivery will start as early as H1’21, following the completion of P-III study and the TGA’s approval of the vaccine. The vaccine regimen is expected to require two doses per …

Novavax Collaborates with Commonwealth of Australia to Supply 40M doses of NVX-CoV2373 for COVID-19 Read More »

CStone Signs a License Agreement with LegoChem for LCB71 to Treat Multiple Cancer Indications

Shots: LCB to receive $10 M as upfront, and up to $353.5M as cumulative milestone payments along with royalties on sales of LCB71. CStone get an exclusive global right to lead the development and commercialization of LCB71 outside the Republic of Korea The collaboration adds the first ADC to CStone’s development pipeline, bolstering its precision …

CStone Signs a License Agreement with LegoChem for LCB71 to Treat Multiple Cancer Indications Read More »

BMS Signs a Five-Year Agreement with Insitro to Develop Therapies for ALS and Frontotemporal Dementia

Shots: Insitro to receive $50M as up front, $20M as near-term operational milestones and is eligible to receive ~$2B+ as discovery, development, regulatory and commercial milestones along with royalties on sales of the therapies BMS will lead the clinical development, regulatory submissions, and commercialization activities. Insitro will apply its insitro Human (ISH) platform, to create …

BMS Signs a Five-Year Agreement with Insitro to Develop Therapies for ALS and Frontotemporal Dementia Read More »

GSK Presents Results of Maternal & Older Adults RSV Vaccines at IDWeek 2020

Shots: GSK reported that its RSV vaccines for maternal immunization (GSK3888550A) and older adults (GSK3844766A) were well-tolerated and highly immunogenic in P-I/II clinical studies. Both the candidate vaccines contain a recombinant RSVPreF3, that triggers the required immune response The GSK3844766A was first tested in 48 healthy adults (18-40yrs.) & then in 1005 healthy older adults …

GSK Presents Results of Maternal & Older Adults RSV Vaccines at IDWeek 2020 Read More »

Novo Nordisk Signs a License Agreement with Chugai for Antibody Engineering Technologies

Shots: Chugai will receive an upfront, development milestone and royalties if the compound is launch as an approved Ab drug. Additionally, Chugai will receive a fee for technology access Novo Nordisk to get the rights to use several Chugai Ab engineering technologies for their research activities and optional right for the development and marketing of …

Novo Nordisk Signs a License Agreement with Chugai for Antibody Engineering Technologies Read More »

Babyscripts Forms Commercial Partnership with Roche to Develop RPM Programs for Pregnancy

What You Should Know:   – Babyscripts today announced a commercial partnership with Roche Diagnostics, a division of the world’s largest biotech company and a global pioneer in pharmaceuticals and diagnostics.  – Roche will partner with Babyscripts on the development of Babyscripts’ remote patient monitoring (RPM) programs to leverage groundbreaking data science through the next generation of RPM in …

Babyscripts Forms Commercial Partnership with Roche to Develop RPM Programs for Pregnancy Read More »

Ori Biotech Lands $30M for Cell and Gene Therapy Manufacturing Platform

What You Should Know: – Biotech startup Ori Biotech raises $30M in Series A funding to scale its cell and gene therapy (CGT) manufacturing platform. – Ori Biotech helps pharmaceutical and biotech companies develop and manufacture cell and gene therapies. Its patented technology aims to reduce the manufacturing cost of these life-saving treatments by up …

Ori Biotech Lands $30M for Cell and Gene Therapy Manufacturing Platform Read More »

Regeneron’s Inmazeb (atoltivimab, maftivimab, and odesivimab) Receives the US FDA’s Approval as the First Treatment for Ebola

Shots: The approval is based on the PALM trial assessing Inmazeb vs Zmapp and remdesivir in 681 adult and pediatric patients including newborns of mothers who have tested positive for the infection. The study demonstrated 1EPs of mortality @28days (33.5% vs 51.3%) and 2EPs of reduction in days until the virus was undetectable in the …

Regeneron’s Inmazeb (atoltivimab, maftivimab, and odesivimab) Receives the US FDA’s Approval as the First Treatment for Ebola Read More »

Roche Signs a License Agreement with Dyno to Develop AVV Gene Therapy for ~$1.8B

Shots: Dyno to receive upfront and is eligible to receive ~$1.8B milestones including development and commercial milestones along with royalties on any product emerges during the collaboration Dyno will be responsible for the design of novel AAV capsids with improved functional properties for gene therapy while Roche and Spark will conduct preclinical, clinical, and commercialization …

Roche Signs a License Agreement with Dyno to Develop AVV Gene Therapy for ~$1.8B Read More »

Inhaled and Intranasal Drug Delivery: A Deeper Look into Service Providers Landscape

The techniques used for the drug delivery are found to be have an enormous impact on the efficacy of the treatment. In fact, the slow progression of the efficacy, has suggested the need of different approaches for the effective delivery of drug to the target area, along with the optimal bioavailability. Over the years, several …

Inhaled and Intranasal Drug Delivery: A Deeper Look into Service Providers Landscape Read More »

J&J to Supply EU with up to 400M Doses of its COVID-19 Vaccine

Shots: EC has approved an advance purchase agreement in which the Janssen will supply 200 M doses of thw COVID-19 vaccine candidate to EU member states following approval from regulators. Additionally, the EU member states have an option to secure up to 200M additional doses The agreement follows the conclusion of exploratory talks with the …

J&J to Supply EU with up to 400M Doses of its COVID-19 Vaccine Read More »

Merck Signs an Out-Licensing Agreement with Novartis for M6495 (Anti-ADAMTS5 Nanobody) for Osteoarthritis

Shots: Merck to receive an € 50M upfront payment and € 400M development and commercial milestones and royalties on future net sales. Novartis will hold full responsibility for the development and commercialization of the M6495 program Two P-I studies were completed with M6495 where NCT03224702 in healthy volunteers demonstrated safety and tolerability and reduction of …

Merck Signs an Out-Licensing Agreement with Novartis for M6495 (Anti-ADAMTS5 Nanobody) for Osteoarthritis Read More »

Moderna’s mRNA-1273 COVID-19 Vaccine Demonstrate Immune Responses in Older Adults

Shots: Moderna reported the publication of the second interim analysis of the open-label P-I study of mRNA-1273 in the NEJM. The study evaluated a 2dose vaccination schedule of mRNA-1273 given 28 days apart in 40 adults across two dose levels (25/100µg) in two age cohorts (56-70/ 71+) and reports results @Day 57 (1mos. following the …

Moderna’s mRNA-1273 COVID-19 Vaccine Demonstrate Immune Responses in Older Adults Read More »

Taysha Gene Therapies’ TSHA-101 Receives the US FDA’s Orphan Drug Designation and Rare Pediatric Disease Designation for GM2 Gangliosidosis

Shots: The US FDA has granted ODD and RPD to the Taysha Gene Therapies’ TSHA-101 for GM2 Gangliosidosis. The company expects the therapy to enter the clinic by the end of 2020 The US FDA’s two designations demonstrated the strength of the translational data package supporting TSHA-101 for GM2 Gangliosidosis TSHA-101 is an AAV9-based gene …

Taysha Gene Therapies’ TSHA-101 Receives the US FDA’s Orphan Drug Designation and Rare Pediatric Disease Designation for GM2 Gangliosidosis Read More »

BioNTech and Fosun Pharma to Supply ~10M Doses of COVID-19 Vaccine to Hong Kong and Macao

Shots: BioNTech and Fosun collaborated to supply 10M doses of their BNT162 mRNA-based vaccine candidate against COVID-19 to Hong Kong SAR and Macao SAR, once approved Fosun Pharma has signed the Letter of Intent with Jacobson for contemplated distribution of 10M doses of a vaccine targeting COVID-19 in the Chinese market On Mar 13, 2020, …

BioNTech and Fosun Pharma to Supply ~10M Doses of COVID-19 Vaccine to Hong Kong and Macao Read More »

BeiGene Signs an Exclusive License Agreement with Singlomics for Neutralizing COVID-19 Antibodies

Shots: Singlomics to receive upfront and is eligible to receive regulatory & commercial milestones along with royalties on sales of products. BeiGene get an exclusive global right (Ex-China) to develop & commercialize its preclinical assets (DXP-593 and DXP-604), as well as for a series of Ab sequences targeting COVID-19 The companies plan to initiate P-I …

BeiGene Signs an Exclusive License Agreement with Singlomics for Neutralizing COVID-19 Antibodies Read More »

COVID-19 is causing a renaissance in the UK biotech sector, we must ensure it lasts

Despite the UK’s world class research output and the many start-ups successfully spinning out from its academic institutions, in recent years UK biotech companies have struggled to access the capital they need to scale up and make their mark on the industry. The COVID-19 pandemic has brought about a radical transformation, with investors now eager …

COVID-19 is causing a renaissance in the UK biotech sector, we must ensure it lasts Read More »

AstraZeneca Initiates P-I Study of AZD7442 Against COVID-19

Shots: The first participants have been dosed in a P-I trial of AZD7442 to assess safety, tolerability, and PK of the combination mAbs in up to 48 healthy participants aged 18-55 yrs. in the UK. The study is funded by DARPA If AZD7442 proves to be tolerated and has a favorable safety profile in the …

AstraZeneca Initiates P-I Study of AZD7442 Against COVID-19 Read More »

Merck’s Keytruda (pembrolizumab) Receives Two New PMDA’s Approvals in Japan

Shots: The first approval is for certain ESCC patients, which is based on P-III KEYNOTE-181 trial assessing Keytruda vs CT in patients with recurrent or metastatic ESCC whose tumors expressed PD-L1 (CPS ≥10). The study demonstrated mOS (10.3 vs 6.7mos.) Additionally, Keytruda received approval for use at an additional recommended dosage of 400mg, q6w, IV …

Merck’s Keytruda (pembrolizumab) Receives Two New PMDA’s Approvals in Japan Read More »

Novartis’ Triple Regimen Fails to Meet the Primary Endpoint in P-III COMBI-i Study for Advanced Melanoma

Shots: The P-III study involves assessing of spartalizumab (PDR001) + Tafinlar (dabrafenib) and Mekinist (trametinib) vs PBO + Tafinlar and Mekinist in previously untreated patients with unresectable or metastatic BRAF V600 mutation-positive melanoma The study was conducted in three parts while today’s results are from part 3 of the trial. The study did not meet …

Novartis’ Triple Regimen Fails to Meet the Primary Endpoint in P-III COMBI-i Study for Advanced Melanoma Read More »

ReiThera Reports First Patient Dosing with its COVID-19 Vaccine Candidate in Italy

Shots: The first healthy volunteer has been dosed in a P-I study of GRAd-COV2 against COVID-19 which is conducted by the Lazzaro Spallanzani National Institute for Infectious Diseases under the sponsorship of ReiThera The P-I study will evaluate the safety & immunogenicity of GRAd-COV2 in 90 healthy volunteers divided equally into two age cohorts: 18-55yrs. …

ReiThera Reports First Patient Dosing with its COVID-19 Vaccine Candidate in Italy Read More »

Chugai’s Kadcyla (trastuzumab emtansine) Receives MHLW’s Approval for Adjuvant Therapy of HER2-Positive Early Breast Cancer

Shots: The approval is based on P-III KATHERINE study assessing Kadcyla (100/160mg, IV) adjuvant therapy in 1486 patients with HER2+ early BC who did not have pathologic complete response following neoadjuvant therapy including Herceptin The results showed the superiority of Kadcyla over Herceptin in terms of the 1EPs of invasive disease-free survival. The safety profile …

Chugai’s Kadcyla (trastuzumab emtansine) Receives MHLW’s Approval for Adjuvant Therapy of HER2-Positive Early Breast Cancer Read More »

AstraZeneca’s Imfinzi (durvalumab) Receives MHLW’s Approval for Extensive-Stage Small Cell Lung Cancer

Shots: The approval is based on P-III CASPIAN study assessing Imfinzi + etoposide and either carboplatin/ cisplatin CT or Imfinzi & CT+ tremelimumab vs CT as monothx. as 1L treatment in 805 patients with ES-SCLC. The trial used an FD of Imfinzi (1,500mg, q3w for 4 cycles) while in combination with CT and then q4w …

AstraZeneca’s Imfinzi (durvalumab) Receives MHLW’s Approval for Extensive-Stage Small Cell Lung Cancer Read More »

Pfizer and BioNTech Plan for Regulatory Review of its COVID-19 Vaccine in October 2020

Shots: The companies have shared additional P-I safety and immunogenicity data from their ongoing US study of the BNT162b2 against SARS-CoV-2, which has advanced into P-II/III evaluation. Across all populations, BNT162b2 was well tolerated with mild to moderate fever in fewer than 20% of the participants In P-I study, BNT162b2 (@7days after the second dose …

Pfizer and BioNTech Plan for Regulatory Review of its COVID-19 Vaccine in October 2020 Read More »

Novartis’ Kesimpta (ofatumumab) Receives the US FDA’s Approval as the First Self-Administered Therapy for Relapsing Multiple Sclerosis

Shots: The approval is based on P-III ASCLEPIOS I & II studies assessing Kesimpta (20mg, monthly, SC) vs teriflunomide (14mg, qd) in 1,882 patients aged 18-55yrs. with RMS with an EDSS b/w 0 and 5.5 across 37 countries. Additionally, P-II APLIOS study determine the bioequivalence of subcutaneous delivery of Kesimpta via a prefilled syringe and …

Novartis’ Kesimpta (ofatumumab) Receives the US FDA’s Approval as the First Self-Administered Therapy for Relapsing Multiple Sclerosis Read More »