Pharma

Better late than never? Eczema drug now approved, Incyte says warning unwarranted

Atopic dermatitis patients now have a new option that comes as a topical cream. The FDA approved Incyte’s drug, Opzelura, as a treatment for the inflammatory skin condition, but the regulatory nod comes with a black box warning on the label that broadly covers the entire class of JAK inhibitors.

Takeda Enters into an Exclusive License Agreement with Mirum to Develop and Commercialize Maralixibat for Rare Pediatric Liver Diseases in Japan

Shots: Takeda will lead the regulatory approval and commercialization of maralixibat in Japan & will also be responsible for the development, including conducting clinical studies in cholestatic indications The collaboration will utilize Takeda’s leadership in rare disease, gastroenterology, and hepatology to advance the product in Japan Mirum has submitted a maralixibat’s NDA to the US …

Takeda Enters into an Exclusive License Agreement with Mirum to Develop and Commercialize Maralixibat for Rare Pediatric Liver Diseases in Japan Read More »

Seagen, Genmab antibody drug conjugate gets FDA approval in cervical cancer

The Seagen and Genmab antibody drug conjugate (ADC), named Tivdak, is approved to treat cases of cervical cancer that have returned or spread following treatment with chemotherapy. Tivdak is Seagen’s third ADC; for Genmab, the drug will become its first commercialized product.

Amgen Collaborates with Verastem to Evaluate VS-6766 + Lumakras (Sotorasib) in P-I/II Trial for KRAS G12C-Mutant Non-Small Cell Lung Cancer

Shots: The companies collaborated to evaluate the safety, tolerability & efficacy of Verastem’s VS-6766 + Amgen’s Lumakras in the P-I/II trial for patients with KRAS G12C-mutant NSCLC who have not been previously treated with a KRAS G12C inhibitor & who have progressed on a KRAS G12C inhibitor. The trial is expected to start at the …

Amgen Collaborates with Verastem to Evaluate VS-6766 + Lumakras (Sotorasib) in P-I/II Trial for KRAS G12C-Mutant Non-Small Cell Lung Cancer Read More »

Biogen and Samsung land FDA approval for biosimilar to blockbuster Roche drug

The FDA has approved the first biosimilar that references the blockbuster Roche drug Lucentis. The Biogen and Samsung BioLogics joint venture that developed the biologic product have approval to treat three eye conditions that lead to vision loss.

Pfizer reports positive Covid-19 vaccine data in kids; FDA is filing coming

A lower-dose version of Pfizer and BioNTech’s Covid-19 vaccine showed safety and efficacy results in children 5 to 11 that were comparable to those in an older age group. With these preliminary data, the companies said they plan to seek emergency use authorization of the shots.

Everest Enter into an Exclusive License Agreement with Sinovent and SinoMab to Develop and Commercialize XNW1011 for Renal Diseases

Shots: Sinovent & SinoMab to receive $12M up front, ~$549M in development, regulatory & commercial milestone along with royalties on net sales of a product The agreement will strengthen Everest’s leadership in developing novel therapies for renal disease in Greater China & Asia. The agreement also includes technology transfer of manufacturing process to Everest for …

Everest Enter into an Exclusive License Agreement with Sinovent and SinoMab to Develop and Commercialize XNW1011 for Renal Diseases Read More »

Repligen sees $150M Avitide acquisition as key to reaching gene therapy goals

Bioprocessing technologies company Repligen is acquiring Avitide, and its biologics purifying technology, in a $150 million cash and stock deal. Repligen said Avitide will help it meet growing demand for gene therapy solutions.

FDA panel backs booster shots in high-risk groups after rejecting broader proposal

An FDA advisory panel voted down a proposal for booster shots of the Pfizer/BioNTech Covid-19 in the general population, opting instead to support third shots in certain high-risk groups, such as the elderly. Panelists want to see more information supporting the need for a booster, as well as data about a heart safety risk the …

FDA panel backs booster shots in high-risk groups after rejecting broader proposal Read More »

Brain data startup Rune Labs reveals $23M, plans to rev up neuro drug R&D

Rune Labs developed software that aggregates brain data, providing insights for clinical care and clinical research. Health systems are starting to adopt the technology, and the startup has now raised $22.8 million to grow that part of the business while also expanding use of the technology in drug development.

Takeda therapy gets speedy FDA nod for lung cancers with rare genetic signature

Takeda Pharmaceutical drug mobocertinib was approved by the FDA to treat non-small cell lung cancer in patients whose tumors carry a rare genetic signature. With the approval, Takeda can offer an oral alternative to a recently approved Johnson & Johnson drug that targets the same mutation but is given as an infusion.

Biogen to Initiate P-IIIb ASCEND Study Evaluating Higher Doses of Spinraza (nusinersen) for the Treatment of Spinal Muscular Atrophy

Shots: The P-IIIb ASCEND study will evaluate the clinical outcomes & safety of the higher doses of nusinersen in 135 patients aged 5-39yrs. with SMA prior treated with Evrysdi at MRD (5mg). Patients will receive 2 loading doses of nusinersen (50mg, 2wks. apart), followed by a maintenance dose of 28mg, q4mos. in study period & …

Biogen to Initiate P-IIIb ASCEND Study Evaluating Higher Doses of Spinraza (nusinersen) for the Treatment of Spinal Muscular Atrophy Read More »

Dice’s IPO roll comes up with $204M for R&D of oral drugs to rival biologics

Dice Therapeutics raised $204 million from its IPO to support development of oral drugs that could compete against biologic drugs that are injected or infused. Also debuting on the public markets were Tyra Biosciences and Procept BioRobotics.

Theravance’s lead drug fails in Phase 3, triggers a restructuring cutting 75% of staff

The clinical trial failure of Theravance Biopharma’s most advanced internal program, a drug for a rare blood pressure disorder, is leading to a companywide restructuring. Going forward, the biotech will focus on developing drugs for respiratory disorders.

Neuro startup Vanqua Bio emerges with $85M and a first focus on Parkinson’s

Vanqua Bio aims to treat rare form of Parkinson’s disease by boosting activity of an enzyme that is deficient in patients who have a particular genetic mutation. With $85 million in Series B financing, the biotech startup, which is based on Northwestern University research, aims to reach human testing within two years.

Astellas Pharma reports fourth patient death in gene therapy clinical trial

The death occurred less than two weeks after Astellas Pharma reported that the patient developed liver problems after being dosed with the experimental gene therapy for a rare neuromuscular disorder. Astellas said the cause of death is still under investigation, and the FDA has placed a clinical hold on the study.

AI as Business Leverage in Pharma & Life Sciences

If there was an AI solution in the Life Sciences field, able to represent a real opportunity in terms of Customer Engagement and Digital Transformation, and if some of the most important players in the industry already had it, would you like to have the opportunity to listen to them?    This and other trend …

AI as Business Leverage in Pharma & Life Sciences Read More »

Nuformix Signs an Exclusive WW License Agreement with Oxilio to Develop NXP001 for Oncology Disease

Shots: Nuformix is eligible to receive an up front, development milestone along with royalties when the net sales reaching $2.76M/annum Oxilio gets an exclusive license to research, develop and commercialize NXP001 globally for oncology indications. The agreement allows Oxilio to focus on developing a unique formulation and dosage form with NXP001 to progress into the …

Nuformix Signs an Exclusive WW License Agreement with Oxilio to Develop NXP001 for Oncology Disease Read More »

Startup Walking Fish nabs $50M to run with B cell therapies for cancer & more

Walking Fish Therapeutics is developing cell therapies from B cells, a type of immune cell that produces prodigious amounts of proteins. Cancer, autoimmune disease, and regenerative medicine are among the targets of the preclinical-stage biotech, which unveiled $50 million in funding.

AbbVie makes another gene therapy move, paying $370M to partner with Regenxbio

AbbVie will take the lead on commercializing Regenxbio’s gene therapy in wet AMD and diabetic retinopathy. It’s AbbVie’s second major gene therapy deal this year, coming months after it committed $90 million to preclinical-stage Capsida Biotherapeutics.

AbbVie Collaborates with Regenxbio to Develop and Commercialize RGX-314 for the Treatment of Retinal Diseases

Shots: Regenxbio to receive $370M up front in addition to ~$1.38B as development, regulatory and commercial milestones along with royalties on net sales of RGX-314 outside the US. The transaction is expected to close at the end of 2021 Regenxbio will be responsible for the manufacturing, clinical development & commercial supply for the therapy in …

AbbVie Collaborates with Regenxbio to Develop and Commercialize RGX-314 for the Treatment of Retinal Diseases Read More »

FDA sets expectations for pediatric Covid-19 vaccines; decision could come mid-fall

Acknowledging the demand for a Covid-19 vaccine for children, the FDA said it expects regulatory review could take weeks, not months, depending on the timing of a submission from vaccine developers. U.S. health officials told Reuters they expect the Pfizer/BioNTech vaccine will be the first one ready for an FDA submission.

FDA warns Kaleido Bio to test its Covid-19 candidate as a drug, not a medical food

The FDA issued a warning letter to Kaleido Biosciences alleging the company tested its experimental microbiome product in Covid-19 patients without submitting a formal clinical trial application. Kaleido claims the filing was not required because the product is a medical food, but the regulator doesn’t buy that argument.

Genetic meds pioneer James Wilson has a new startup, this time in gene editing

Biotech startup iECURE is based on work from the University of Pennsylvania scientist, who has been researching ways to use in vivo gene editing as a way to “knock in” healthy versions of a gene to treat rare liver diseases. The company, which will develop therapeutic candidates from Penn, has raised $50 million in Series …

Genetic meds pioneer James Wilson has a new startup, this time in gene editing Read More »

Startup A-Alpha Bio sets out to solve a major protein problem facing big pharma

A-Alpha Bio’s technology analyzes millions of protein-protein interactions simultaneously, a capability that speeds up drug discovery research. Biotech industry partners are already using the technology and now with $20 million in Series A funding, the startup plans to build machine-learning capabilities to crunch the data produced by all of those protein interactions.

AM-Pharma Enters into an Exclusive License Agreement with Kyowa Kirin to Commercialize Ilofotase Alfa in Japan

Shots: AM-Pharma to receive $23.6M up front, $35.4M in milestones before regulatory submission and ~$230.4M upon submission, NHI price listing & sales milestone along with royalties on sales and a drug supply fee Kyowa Kirin to get the exclusive right to develop and commercialize ilofotase alfa in Japan. Ilofotase alfa is currently being evaluated in …

AM-Pharma Enters into an Exclusive License Agreement with Kyowa Kirin to Commercialize Ilofotase Alfa in Japan Read More »

Roche bets $300M on Adaptimmune tech for off-the-shelf cell therapies for cancer

Roche is partnering with Adaptimmune Therapeutics to develop allogeneic cell therapies based on Adaptimmune’s technology. In addition to these “off-the-shelf” products, the partners will also develop a personalized allogeneic cell therapy designed specifically for a patient’s cancer.

Cancer concerns lead FDA to place clinical hold on BioMarin gene therapy

A Phase 1/2 study of BioMarin Pharmaceutical’s gene therapy for phenylketonuria has been placed under a clinical hold after interim results from a preclinical study showed that some mice developed liver tumors. Patients did not receive the same high dose that was given to the mice, and no one in the clinical trial has developed …

Cancer concerns lead FDA to place clinical hold on BioMarin gene therapy Read More »

Dr. Reddy’s Collaborates with Citius to Sell Rights of its Anti-Cancer Agent (E7777)

Shots: Dr. Reddy’s to receive $40M up front upon the closing of the transaction, followed by ~$40M milestones on E7777’s approval in CTCL and ~$70M for additional indication approvals. Additionally, Dr. Reddy’s will receive commercial milestones and royalties Citius to get all the rights to E7777 (an engineered IL-2-diphtheria toxin fusion protein) and certain related …

Dr. Reddy’s Collaborates with Citius to Sell Rights of its Anti-Cancer Agent (E7777) Read More »

Impel NeuroPharma’s drug-device combo product nabs FDA nod for migraine

The FDA improved an Impel NeuroPharma migraine treatment, a nasal spray intended to bring pain relief more quickly than drugs administered in other ways. It marks the first approval for the Seattle company, which has developed a proprietary nasal delivery technology.

Novartis “one transplant for life” drug flunks test in kidney transplant patients

A Novartis drug intended to prevent organ rejection has failed to beat out the standard of care therapy in a Phase 2 study in kidney transplant patients. Other clinical trial failures announced ahead of the Labor Day weekend include a Forte Biosciences atopic dermatitis drug, as well a cancer therapy from Takeda Pharmaceutical.

Blood disorder biotech Disc Medicine gets $90M to bring two drugs into Phase 2

A Roche drug that failed as a treatment for neurological disorders is now the lead program for Disc Medicines. CEO John Quisel said Roche’s clinical data showed the small molecule’s promise addressing a rare blood disorder and now the biotech startup has $90 million to advance that drug and another one into Phase 2 testing.

Assembly Bio drops hepatitis B drug after liver problems surface in clinical trial

Four patients dosed with an experimental Assembly Biosciences hepatitis B treatment developed high levels of liver enzymes, a sign of drug-induced liver toxicity. The biotech has decided to stop further work on that drug and focus instead on developing its other clinical-stage hepatitis B drugs.

FDA cracks down on JAK drug class, calls for new warnings of heart, cancer risks

The FDA’s review of a post-marketing study for Pfizer blockbuster anti-inflammatory drug Xeljanz found a higher risk of cardiovascular problems and cancer, and the agency is requiring additional warnings flagging those risks. The updated warnings extend to AbbVie and Eli Lilly medicines in the same drug class.

Asher Bio’s encouraging early data against rival cancer drug sparks $108M financing

Five months after raising $55 million to back a new technology and a promising lead cancer immunotherapy, Asher Biotherapeutics has reeled in $108 million more. CEO Craig Gibbs said investors were enticed by encouraging new data suggesting Asher Bio’s lead program is superior to a competitor’s.

Versanis Bio unveils $70M and a Novartis drug ready for Phase 2 test in obesity

Novartis was unsuccessful developing bimagrumab as a treatment for a rare muscle disorder, but additional tests showed encouraging results in fat reduction. Startup Versanis Bio licensed rights to the antibody and plans to use its Series A financing for clinical trials testing the drug in obese patients.

Pathway To Effective Stakeholder Mapping

Before developing any stakeholder engagement plan, it is crucial to have a clear understanding of all the relevant individuals and groups your product or device could directly impact or interest in some way. Stakeholders within the pharmaceutical world encompass many diverse groups and include payers, government bodies, standard-setting bodies, physicians, key opinion leaders, patients, and …

Pathway To Effective Stakeholder Mapping Read More »

Catalent sees $1B Bettera deal as a key to growth in nutrition and consumer health

Tie-ups of candy makers and nutritional product companies into a single firm called Bettera has culminated in a $1 billion acquisition by Catalent. The global contract manufacturing giant plans to leverage Bettera’s ability to produce gummies and chewables as a way to offer its customers new formulation options for nutraceutical products.

Pfizer eczema contender beats Dupixent in study, but JAK drug class is still in limbo

Pfizer has preliminary data showing its experimental drug for atopic dermatitis beat a blockbuster drug from Regeneron Pharmaceuticals in a head-to-head clinical trial. But the future of that drug and others might depend more on an FDA review of safety data for medicines in this class of so-called JAK inhibitors.

How Pharma Startups Can Remain Competitive in Today’s Market

Aaron Ferguson, COO and co-founder of Vytal Challenging the status quo is never easy. Neither is being the underdog. Startups face both of these challenges when trying to break into existing industries dominated by well-established players.  Differences in the size, speed, processes, and culture of a company make it challenging for all startups to compete, …

How Pharma Startups Can Remain Competitive in Today’s Market Read More »

BioMarin stands tall with first approved drug for rare disease that causes dwarfism

The European Commission has approved a BioMarin Pharmaceutical drug that treats achondroplasia, a rare genetic disorder that slows bone growth and is the most common cause of dwarfism. The commission also granted conditional approval to a cancer drug from partners Incyte and MorphoSys.

BeyondSpring Signs an Exclusive Agreement with Jiangsu Hengrui to Co- Develop & Commercialize Plinabulin in Greater China

Shots: Wanchunbulin to receive $30M up front, $170M as regulatory and sales milestone & is eligible to receive $15M as equity investment at a pre-money valuation of $560M Hengrui gets exclusive rights to commercialize & co-develop plinabulin in Greater China and will be accountable for all costs associated with the commercialization of plinabulin in the …

BeyondSpring Signs an Exclusive Agreement with Jiangsu Hengrui to Co- Develop & Commercialize Plinabulin in Greater China Read More »

ADC Therapeutics strikes a $325M royalty deal to fuel its cancer drug strategy

The royalty agreement with HealthCare Royalty Partners will support ADC Therapeutics’ plans to commercialize its newly approved cancer drug and develop the next one in its pipeline. The biotech’s drug Zynlonta is the first of its type approved by the FDA as a treatment for diffuse large cell B-cell lymphoma

Eli Lilly aims for the next-generation of protein degraders via Lycia R&D alliance

Eli Lilly is entering the field of protein-degrading drugs through a partnership with Lycia Therapeutics, a startup whose technology goes further than the first wave of such drugs. Lilly paid $35 million to begin the alliance, which spans up to five drugs.

Scant on details, J&J claims it has data supporting Covid-19 booster shots

As U.S. plans for Covid-19 booster shots unfold, Johnson & Johnson is angling to join the mix, reporting data that it says support a second shot of its vaccine. But the data the company points to are sparse and it’s not entirely clear they support booster shots.

FDA approves first drug for severe itching in chronic kidney disease patients

Chronic kidney disease patients who experience pruritus after dialysis can now get relief from the first FDA-approved treatment for the condition. Cara Therapeutics received the FDA’s nod green light for its injectable drug, Korsuva.

Theravance’s Janssen Biotech-partnered ulcerative colitis drug flops in Phase 2

The Theravance Biopharma drug is the lead program in an alliance with Johnson & Johnson subsidiary Janssen Biotech, which paid $100 million up front to develop the JAK inhibitor for intestinal diseases. Following the Phase 2 failure, Theravance said it will minimize spending on that program.

Takeda Signs a License Agreement with Genevant to Develop and Commercialize Novel Nonviral Gene Therapies for Liver Diseases

Shots: Genevant is eligible to receive ~$303M up front and milestone along with royalties on future product sales Takeda gets exclusive rights to use Genevant’s LNP technology for the development and commercialization of specified nonviral gene therapies for up to two undisclosed rare liver diseases The collaboration follows the initial 2021 agreement in which companies …

Takeda Signs a License Agreement with Genevant to Develop and Commercialize Novel Nonviral Gene Therapies for Liver Diseases Read More »

Pfizer makes big move in blood cancers with $2.3B Trillium acquisition

Though Gilead Sciences leads the group of companies developing immunotherapies that target the cancer protein CD47, Pfizer contends that molecules it is getting through the Trillium Therapeutics acquisition have safety and efficacy advantages that could make them the best in this emerging drug class.

Pfizer, BioNTech Covid-19 vaccine is awarded full FDA approval

Full FDA approval makes the Pfizer/BioNTech Covid-19 vaccine the first to reach that milestone. But the regulatory decision also flagged a potential risk of heart inflammation, particularly in young males, and the agency has asked the companies to conduct additional clinical research.

Four biotech startup reel in $238M in financing to ramp up for clinical trials

Vigil Neuroscience led the way with a $90 million round of funding, one of four biotech companies to close Series B financing rounds in the past week. The fresh capital comes as each of the companies looks ahead to bringing their respective drugs into the clinic.

AstraZeneca drug succeeds in Covid-19 prevention; regulatory filings on the way

An AstraZeneca antibody drug for Covid-19 has clinical data showing the drug reduced the risk of infection by 77%. With the results, the pharmaceutical giant pulls ahead of other companies developing injectable versions of antibody drugs for Covid-19 prevention.

AstraZeneca drug acquired in Alexion acquisition falls short in pivotal ALS trial

Alexion Pharmaceuticals drug Ultomiris is already approved to treat a rare blood disorder, but the company hoped the antibody’s approach could also work in amyotrophic lateral sclerosis. Despite failing in ALS, Alexion, recently acquired by AstraZeneca, brings additional clinical-stage programs for rare diseases.

Merck Signs a Supply Agreement with Werewolf for WTX-124 INDUKINE Program to Treat Solid Tumors

Shots: The companies collaborated to evaluate the safety and preliminary efficacy of Werewolf’s WTX-124 as monothx. or in combination with Merck’s Keytruda (anti-PD-1 therapy) in a P-I trial for patients with solid tumors The company plans to submit an IND application for WTX-124 to the US FDA in H2’22 WTX-124 is a systemically delivered, conditionally …

Merck Signs a Supply Agreement with Werewolf for WTX-124 INDUKINE Program to Treat Solid Tumors Read More »

HHS cites real-world data for Covid-19 boosters; WHO says the science is still out

In announcing plans to offer Covid-19 booster shots, federal health officials cited declining vaccine efficacy shown by real-world studies. But the World Health Organization said the science is less than clear about booster shots, adding that it’s ethically wrong to give third shots when so many around the world are waiting for their first one.

FDA decision for GSK drug opens door to treatment of more cancer patients

GlaxoSmithKline drug Jemperli is now FDA approved for treating solid tumors throughout the body as long as they have a particular genetic signature. Expanding the drug’s approval means the drug can treat more patients who have more types of cancer, and it also gives GSK a way to grow revenue in its thin oncology portfolio.

Verily adds to its clinical trials toolbox with acquisition of startup SignalPath

Verily’s recent moves have signaled the company’s interest in supporting decentralized clinical trials and real-world studies. Now the life sciences subsidiary of Alphabet is bolstering its capabilities in this these areas with the acquisition of startup SignalPath.

Gritstone secures CEPI funding to test Covid vaccine; first focus is South Africa

Gritstone bio is developing Covid-19 vaccines that use self-amplifying messenger RNA, which is intended to further boost the immune response compared to mRNA alone. The company also says its vaccine candidates may be able to protect against variants of the novel coronavirus.

Sesen Bio says rejected bladder cancer drug may need new clinical trial

For much of this summer, Sesen Bio said all of the FDA’s communications pointed toward regulatory approval for the biotech’s bladder cancer drug. Though Sesen characterized the regulator’s rejection of the fusion protein as surprising, CEO Tom Cannell also revealed an earlier sign that another clinical trial may be necessary.

Merck drug acquired in $1B deal approved to treat tumors sparked by rare disease

FDA approval of the Merck drug, belzutifan, covers treatment of tumors caused by von Hippel-Lindau disease, an inherited disorder associated with several types of cancer. Merck added the small molecule to its pipeline two years ago as part of a $1.2 billion acquisition.

FDA authorizes Covid-19 booster shots, but only for the immunocompromised

Covid-19 vaccine booster shots are now authorized for organ transplant patients and others who have weakened immune systems. The FDA based its update on the results of two small studies that tested third shots of the mRNA Covid vaccines from Moderna and Pfizer/BioNTech.

Second FDA clinical hold for Aprea cancer drug cites safety data in another study

For the second time in a week, the FDA placed a clinical hold on an Aprea Therapeutics cancer drug. The biotech said the agency cited safety and efficacy data from a prior failed clinical trial that tested the small molecule in a different form of cancer.

Social Health: The Future of Healthcare Marketing

With advertisers preparing to spend up to $15 billion on influencer marketing by 2022, pharmaceutical and biotech companies are increasingly (and carefully) engaging trusted health social influencers to connect more authentically with consumers. As pharma starts to leverage a multitude of high-engagement channels like influencer marketing, online communities and virtual health services, the industry finds itself …

Social Health: The Future of Healthcare Marketing Read More »

Takeda to Advance FIN-524 Development Program in Ulcerative Colitis

Shots: Takeda will lead the development of FIN-524/TAK-524 to treat UC prior to the start of its clinical program & will leverage its expertise in IBD throughout the development process Finch plans to provide ongoing technical support through the P-I trial of FIN-524/TAK-524 in the same indication. The companies will continue to advance the program …

Takeda to Advance FIN-524 Development Program in Ulcerative Colitis Read More »

HIMSS Digital: Future is bright for payer-provider-pharma collaboration

The pandemic made collaboration necessary between stakeholders that otherwise tend to be at odds with each other. But as partnerships grow, providers, payers and pharma companies must ensure they are working toward a clear-cut common goal, according to panelists at HIMSS 21 Digital.

Measuring Advocacy of Digital KOLs

Identifying the most important & active digital experts in your space is just the first step of the engagement planning cycle. Because even within a therapy area, digital KOLs (DOLs) have very different online characteristics – those who tend to initiate online conversations, those that tend to create new content, those that tend to propagate …

Measuring Advocacy of Digital KOLs Read More »

Sanofi’s mRNA strategy adds biggest piece yet with $3.2B Translate Bio buyout

Sanofi is acquiring Translate Bio, its messenger RNA R&D partner for the past three years, in a $3.2 billion deal. The pharmaceutical and vaccines giant said the acquisition will speed up development of partnered vaccine programs and spark work on new ones in areas such as cancer, immunology, and rare diseases.

Ipsen bets on Exicure’s tech as better way to deliver neuro drugs deep into the brain

Ipsen is shoring up its neuroscience pipeline via a deal that gives it the option to license drugs that Exicure is developing for Huntington’s disease and Angelman syndrome. The programs are based on Exicure’s proprietary technology that produces nucleic acid therapies capable of delivery deep into the brain.

Icosavax’s $182M IPO haul is key for RSV, but eyes are on its Covid vaccine too

Icosavax’s research developing a vaccine for a virus that can lead to deadly respiratory infections in the very young and the very old has found an additional application in the pursuit of a vaccine for the novel coronavirus. The biotech’s $182 million IPO gives it the capital to move forward with clinical research on multiple …

Icosavax’s $182M IPO haul is key for RSV, but eyes are on its Covid vaccine too Read More »

Biogen and Eisai unveil details for five-year, real-world Aduhelm clinical trial

Patients taking new Alzheimer’s disease drug Aduhelm will be evaluated in a real-world study lasting up to five years. Biogen announced plans for the observational study, which is one of three post-marketing clinical programs planned to generate more data about the drug

Junshi Reports NMPA’s Acceptance of sNDA for Toripalimab + CT as 1L Treatment for Advanced or Metastatic Esophageal Squamous Cell Carcinoma

Shots: The sNDA is based on the P-III JUPITER-06 study evaluating toripalimab + CT vs PBO + CT in 514 patients with locally advanced or metastatic ESCC The results of the study showed that toripalimab + CT significantly improved both PFS and OS for patients with advanced or metastatic ESCC, regardless of PD-L1 expression status. …

Junshi Reports NMPA’s Acceptance of sNDA for Toripalimab + CT as 1L Treatment for Advanced or Metastatic Esophageal Squamous Cell Carcinoma Read More »

FDA turns down Ardelyx’s chronic kidney disease drug and asks for another trial

Ardelyx drug tenapanor was rejected by the FDA as a treatment for a complication experienced by chronic kidney disease patients. The regulatory decision came two weeks after the company received an FDA letter citing deficiencies in the drug application.

Janssen Amends its Agreement with Protagonist to Develop and Commercialize IL-23 Antagonists

Shots: Protagonist to receive ~ $900M as development & sales milestones along with $80M already received under the original agreement with royalty rates remain unchanged. Janssen will get right to continue research on IL-23 receptor antagonists developed under a collaboration for 3yrs. following the closing of the amended agreement Janssen will lead all future studies …

Janssen Amends its Agreement with Protagonist to Develop and Commercialize IL-23 Antagonists Read More »

Ring Therapeutics rounds up $117M to find better viral vectors for gene therapy

The engineered viruses used to deliver gene therapies can spark complications and they can’t be re-dosed. Ring Therapeutics says viruses that evolved with humans can be better viral vectors and the startup has raised $117 million in new financing to continue its research.

BridgeBio Enters into Clinical Collaboration with BMS to Evaluate BBP-398 + Opdivo for Advanced Solid Tumors with KRAS Mutations

Shots: The companies will initiate P-I/II study evaluating the safety and preliminary efficacy of BBP-398 in combination with both Opdivo as dual therapy & Opdivo + KRASG12C inhibitor as triplet therapy in NSCLC patients with KRAS mutations, as 1L & 2L treatment options BridgeBio will sponsor the study while BMS will provide nivolumab to the …

BridgeBio Enters into Clinical Collaboration with BMS to Evaluate BBP-398 + Opdivo for Advanced Solid Tumors with KRAS Mutations Read More »

Amgen adds antibody assets and R&D tech with $900M Teneobio acquisition

Amgen is paying $900 million up front to acquire Teneobio, a biotech with technology for discovering and developing antibody drugs. Though Amgen already has its own antibody platform, the company says Teneobio’s technology and drug assets will complement its own.

AC Immune picks up Phase 2-ready drug for Parkinson’s in $58M deal with Affiris

AC Immune is bolstering the Parkinson’s disease portion of its drug pipeline with a deal to acquire a therapeutic vaccine that Affiris is developing for the disorder. Switzerland-based AC Immune plans to advance its new asset to Phase 2 testing.

AstraZeneca and Regeneron Collaborate to Research, Develop and Commercialize Therapies for Obesity

Shots: The companies collaborated to research, develop & commercialize small molecules directed against the GPR75 target with the potential to treat obesity and related co-morbidities The collaboration builds on the findings from the Regeneron Genetics Center of rare genetic mutations in the GPR75 gene associated with protection against obesity and on early joint research initiated …

AstraZeneca and Regeneron Collaborate to Research, Develop and Commercialize Therapies for Obesity Read More »

Improving KOL Virtual Advisory Board Engagements

“Very satisfied” is the consensus of KOLs who participate in our SkyBoard virtual advisory board events. But, from what KOLs tell us, there are also plenty of other ways to improve such virtual events. Before we go on to them, a brief note on terminology: by “Virtual Ad Board” we don’t just mean a live …

Improving KOL Virtual Advisory Board Engagements Read More »

Bristol Myers pulls Opdivo for use in liver cancer amid broader FDA scrutiny of speedy approvals

Bristol Myers Squibb blockbuster drug Opdivo is being pulled from the market after failing to meet the main goal of a confirmatory study. The voluntary withdrawal comes amid broader FDA scrutiny of cancer drugs that were given accelerated approval.

Eye problems in more patients spells end of Adverum’s DME gene therapy program

Adverum Biotechnologies still doesn’t know if its experimental gene therapy caused eye problems reported in April in one patient in its diabetic macular edema study. But four others have since developed similar problems, and the company will no longer continue to develop the therapy for that indication.

CRISPR biotech Caribou Biosciences’ IPO reels in $304M for next-gen cell therapy

Caribou Biosciences’ CRISPR approach to cell therapy sparked strong investor interest, enabling the clinical-stage biotech to upsize its IPO and raise $304 million in the biggest life sciences IPO this week. Absci, Sophia Genetics, and Cytek Biosciences also priced IPOs.

Pfizer commits $1B to Arvinas for share of protein degrading breast cancer drug

Arvinas’ early clinical data for its targeted protein degradation drug for breast cancer drew partnering interest from several companies. Pfizer beat them all with a deal that pays the biotech $1 billion to share in the development and commercialization of this therapy.

Seres Therapeutics microbiome drug flunks Phase 2 test in ulcerative colitis

Seres Therapeutics’ ambitions to treat ulcerative colitis with a microbiome drug were dealt a setback as its experimental therapy failed in Phase 2 testing. The company plans a “rigorous scientific analysis” to assess what happened and to determine the next steps for the program.

FDA nod for Albireo drug makes it the first for children with rare liver disorder

The FDA has approved Bylvay, an Albireo Pharma drug that treats the severe itching experienced by patients with progressive familial intrahepatic cholestasis (PFIC). Prior to this approval, the only treatment options for the rare liver disorder were surgical.

Calliditas Signs a License Agreement with STADA to Commercialize Specialty Therapy for the Treatment of IgA Nephropathy in EU

Shots: Calliditas to receive $24M upfront and is eligible to receive ~$91M as regulatory and commercialization milestones along with royalties on net sales The companies collaborated to develop a new oral formulation that downregulates IgA1 by combining Calliditas’ drug-delivery expertise with STADA’s extensive marketing and sales platform for specialty and nephrology therapies The companies collaborated …

Calliditas Signs a License Agreement with STADA to Commercialize Specialty Therapy for the Treatment of IgA Nephropathy in EU Read More »

Amylyx Pharmaceuticals raises $135M as ALS drug heads to pivotal clinical trial

An amyotrophic lateral sclerosis drug from Amylyx Pharmaceuticals is being prepared for Phase 3 clinical testing on track to begin later this quarter. To support that research, the biotech has raised $135 million in financing.

Frontier Medicines raises $88M for R&D, including potential rival to Amgen cancer drug

Cancer drug developer Frontier Medicines already has a research partnership with AbbVie. Now the preclinical-stage biotech has raised $88.5 million for its own pipeline, including a drug that could offer advantages over a recently approved Amgen cancer therapy.

Cytokinetics stock soars on heart drug data that sets stage for Phase 3 studies

A Cytokinetics drug in development for treating a rare heart disorder has promising Phase 2 data suggesting it could compete against a Bristol Myers Squibb drug currently under FDA review. Cytokinetics plans to advance its small molecule to Phase 3 testing by the end of this year.

Meissa Vaccines’ leg up in the Covid-19 vaccines chase goes through the nose

An intranasal Covid-19 vaccine candidate from Meissa Vaccines could offer advantages compared to injectable ones. The company is still in early clinical development but the company now has data from monkey studies that further build the case for the vaccine.

Regulated digital health explained: What you need to know to stay compliant [Sponsored]

Digital health thought leader Mark Tarby, BrightInsight vice president of regulatory and quality management systems, shared his take on what the EU MDR means for connected devices, Software as a Medical Device (SaMD), and the go-to market strategies for the companies behind them.

Erasca’s IPO leads the way as three cancer biotechs raise $534M for clinical trials

Cancer drug developer Erasca, whose mission is to “erase cancer,” has raised $300 million from its IPO. The clinical-stage biotech addresses a single elusive cancer target; it has multiple programs taking multiple approaches, two of them in human testing and the rest on track to join them.

AcelRx Signs a License Agreement with Aguettant to Commercialize Dzuveo in EU and for Two Pre-Filled Syringe Products in US

Shots: Under Dzuveo agreement, AcelRx to receive ~$55M as an up front and commercial milestones in addition to 35% to 45% revenue share on net sales of Dzuveo. AcelRx will manufacture and supply Dzuveo while Aguettant gets the right to commercialize Dzuveo in the EU As per second agreement, Aguettant has the right to receive …

AcelRx Signs a License Agreement with Aguettant to Commercialize Dzuveo in EU and for Two Pre-Filled Syringe Products in US Read More »

Ipsen Signs an Exclusive WW License Agreement with IRLAB for Mesdopetam to Treat Parkinson Disease

Shots: IRLAB to receive ~$363M, including $28M as up front and ~$335M as development, regulatory and commercial milestones along with royalties on WW net sales of mesdopetam Ipsen get the exclusive WW rights to develop and commercialize mesdopetam (novel dopamine D3-receptor antagonist) which is currently being evaluated in P- IIb clinical trials for patients with …

Ipsen Signs an Exclusive WW License Agreement with IRLAB for Mesdopetam to Treat Parkinson Disease Read More »

Wugen unveils $172M to take natural killer cell therapies to solid tumors

Wugen, a biotech developing “off-the-shelf” natural killer and CAR T cell therapies, has raised $172 million in Series B financing. The company’s lead program has already reached human testing and the new capital will be used to continue that research and advance other pipeline programs to the clinic.

PAQ Therapeutics scores $30M to unleash “Pac Man” drugs on neuro disease

Startup PAQ Therapeutics is developing drugs work like Pac Man, gobbling up components of a cell associated with disease. The biotech has closed $30 million in financing to continue its research, with a neurodegenerative disorder as its lead disease target.

Eli Lilly gets glucose-sensing “smart insulin” via buyout of preclinical Protomer

Eli Lilly has Protomer Technologies, a preclinical startup developing next-generation insulin that senses blood glucose levels and adjusts its activity accordingly. The technology could eliminate the need for multiple insulin injections throughout the day.

Biogen reaches across globe and pays $125M to land its next new MS drug

By paying $125 million up front for rights to multiple sclerosis drug candidate orelabrutinib, Biogen secures a place among those companies trying to treat the disease by targeting a particular enzyme highly expressed in the central nervous system. But Biogen still has some catching up to do.

FDA update warns of potential rare nerve side effect for J&J Covid vaccine

The FDA is cautioning that the Johnson & Johnson Covid-19 vaccine may cause a rare immune response affecting the nerves. A causal link has not been established and the side effect, when observed, is rare, but the vaccine information has been updated to reflect the potential risk.

Hutchmed Reports First Commercial Sale of Orpathys (savolitinib) in China

Shots: Hutchmed receives $25M as milestones at 1st commercial sales of Orpathys in China & will receive fixed royalties of 30% based on all sales under the license agreement with AstraZeneca As per collaboration, Hutchmed is responsible for the clinical development, approvals, manufacturing & supply of Orpathys in China while AstraZeneca is responsible for its …

Hutchmed Reports First Commercial Sale of Orpathys (savolitinib) in China Read More »

Biogen Signs a License Agreement with Innocare for Orelabrutinib to Treat Multiple Sclerosis

Shots: InnoCare to receive $125M as up front & is eligible to receive ~ $812.5M as development & commercial milestones, following the achievement of definite milestones along with royalties on sales of any product resulting from the collaboration Biogen to get exclusive rights for orelabrutinib to treat MS globally & other autoimmune diseases outside of …

Biogen Signs a License Agreement with Innocare for Orelabrutinib to Treat Multiple Sclerosis Read More »

Display Library Technologies: Where do we stand?

Over time, a variety of methods / approaches have been developed for the generation of viable therapeutic leads. These include the hybridoma technology, B-cell cloning, transgenic animal-based techniques, in vitro display methods (using phages, ribosomes, mRNA, and cDNA) and cell surface display methods (involving mammalian, yeast, and bacterial cells). Despite being responsible for the development …

Display Library Technologies: Where do we stand? Read More »

Bayer kidney disease drug gets FDA nod, pitting it against AstraZeneca, J&J meds

The FDA has approved Bayer’s Kerendia to treat chronic kidney disease in patients with type 2 diabetes. The drug is the first in its class, giving the pharma giant an alternative way to compete against medicines already marketed by AstraZeneca and Bayer.

Sigilon hemophilia A cell therapy trial placed on hold after patient complication

A hemophilia A patient in a Sigilon Therapeutics clinical trial developed a well-known complication to treatments for the blood disorder. The potential problem for Sigilon is that its cell therapy is designed to avoid triggering such immune responses.

KOL Influence Maps

Who influences whom? Who’s connected to whom? Who collaborates with whom? These are some of the most important questions that should be answered when creating your target list of KOLs to engage with and building an effective KOL engagement strategy.   Traditionally most KOL influence maps have been built by analysing publication or congress co-authorship …

KOL Influence Maps Read More »

KOL Influence Maps

Who influences whom? Who’s connected to whom? Who collaborates with whom? These are some of the most important questions that should be answered when creating your target list of KOLs to engage with and building an effective KOL engagement strategy.   Traditionally most KOL influence maps have been built by analysing publication or congress co-authorship …

KOL Influence Maps Read More »

Biotech startup using AI to take guesswork out of cancer drug selection raises $70M

Xilis is developing technology that creates a living model of a patient’s tumor, then applies artificial intelligence to determine the best drug or drug combinations to treat the cancer. Clinical trials are planned to test this precision medicine approach and the biotech startup has raised $70 million to fund its research.

Eli Lilly looks to startup Verge Genomics to turn AI analysis into new ALS drugs

Eli Lilly is partnering with startup Verge Genomics in a move intended to add ALS drugs to its neuroscience pipeline. To date, Verge’s artificial intelligence technology has produced programs internal programs in ALS, Parkinson’s, and frontotemporal dementia.

NeRRe nabs £20M to test chronic cough drug in patients with a fatal lung disease

A NeRRE Therapeutics drug that failed a clinical trial for refractory or unexplained chronic cough is getting a second shot as a potential treatment for chronic cough in patients with idiopathic pulmonary fibrosis, a rare lung disorder. The biotech raised £20M to proceed with Phase 2 testing.

Eli Lilly’s $15M investment deepens link to startup developing new class of RNA meds

Two months after Eli Lilly began an alliance with MiNA Therapeutics, a startup developing a new type of RNA therapy, the pharmaceutical giant is making a $15 million equity investment in its partner. MiNA is developing a new class of medicines called small activating RNA therapies.

Provention Bio drug for delaying type 1 diabetes hit with FDA delay of its own

Provention Bio needs to show the FDA that the drug substance produced from its contract manufacturer is comparable to the Eli Lilly-made drug substance that was evaluated in clinical trials. A larger study testing the prospective type 1 diabetes therapy teplizumab is ongoing and could provide the information the agency needs.

Abbisko Signs an Exclusive License Agreement with Sperogenix to Develop ABSK021 for ALS and Other Rare Neurological Diseases in Greater China

Shots: Abbisko to receive upfront, milestones and royalties on net sales of the therapy & hold the rights for all other countries & indications. Sperogenix gets an exclusive right to develop, manufacture & commercialize ABSK021 in mainland China, Hong Kong SAR and Macao SAR for non-oncology rare neurological diseases Sperogenix will be responsible for the …

Abbisko Signs an Exclusive License Agreement with Sperogenix to Develop ABSK021 for ALS and Other Rare Neurological Diseases in Greater China Read More »

CRO Parexel changes private equity hands again, this time for $8.5B

Four years after a private equity acquisition took Parexel private, the contract research organization is being acquired by two private equity firms for $8.5 billion. It’s the latest in a series of acquisitions to hit the CRO sector this year.

GSK adds neuro prospects, paying $700M to share R&D of Alector’s two lead drugs

GlaxoSmithKline is paying Alector $700 million up front to share in the development of the biotech’s two lead drugs, which offer potentially broad application in treating neurological disorders. Alector’s approach addresses the role immune cell dysfunction plays in neurodegenerative disorders such as Alzheimer’s and Parkinson’s disease.

Denovo In-Licenses Lundbeck’s Idalopirdine for Alzheimer’s Disease and Other Indications

Shots: Denovo has licensed the global rights for idalopirdine including all rights to develop, manufacture and commercialize idalopirdine for all indications. Lundbeck gets an option to reacquire idalopirdine. If Lundbeck exercise the option, both the companies will share rights of the product in China and if not, Denovo will retain all global rights to the …

Denovo In-Licenses Lundbeck’s Idalopirdine for Alzheimer’s Disease and Other Indications Read More »

Almirall and Kaken Enter into a License Agreement for the Development and Commercialization of Efinaconazole in Europe

Shots: Kaken to receive an up front in cash and is eligible to receive milestones and royalties on the sales of the product. Almirall plans to have a pre-submission meeting with regulatory authorities in next year to prepare the approval of the product in the EU Almirall get the exclusive rights for the development and …

Almirall and Kaken Enter into a License Agreement for the Development and Commercialization of Efinaconazole in Europe Read More »

All in on amyloid, Acumen Pharma’s IPO raises $160M for Alzheimer’s drug R&D

Acumen Pharmaceuticals’ IPO raised $160 million to fund clinical development of its Alzheimer’s disease drug candidate. Though that drug goes after the same target as Biogen’s recently approved Aduhelm, Acumen says its antibody has potential dosing and safety advantages.

Orchard Collaborates with Pharming to Develop and Commercialize OTL-105 for Hereditary Angioedema

Shots: Orchard to receive $17.5M up front including $10M in cash & $7.5M as equity investment at a premium to Orchard’s share and is also eligible to receive ~$189.5M as other milestones along with royalties on WW sales Pharming has granted WW rights to OTL-105 (ex vivo HSC gene therapy) & will be responsible for …

Orchard Collaborates with Pharming to Develop and Commercialize OTL-105 for Hereditary Angioedema Read More »

Apellis and Beam Sign a Five-Year Research Collaboration to Discover Novel Therapies for Complement-Driven Diseases

Shots: Beam to receive $50M up front and $25M as near-term milestones & will be eligible to receive other milestones along with royalties on sales, following the exercise of the option. The companies will work on 6 research programs focusing on C3 & other complement targets in the eye, liver, and brain Apellis holds exclusive …

Apellis and Beam Sign a Five-Year Research Collaboration to Discover Novel Therapies for Complement-Driven Diseases Read More »

Apellis taps Beam’s base-editing tech to broaden autoimmune disease scope

Fresh off its first FDA approval, Apellis Pharmaceuticals is teaming up with Beam Therapeutics, a partnership that will use Beam’s base-editing technology to develop new therapies for complement system disorders. Apellis has committed to pay Beam $75 million to kick off the alliance.

Not yet in the clinic, Pardes Bio’s Covid-19 pill still fills in Foresite’s blank check

Pardes Biosciences advanced from concept to drug candidate in less than nine months. The preclinical biotech is developing an oral antiviral for Covid-19 and other coronavirus infections and it is going public in a SPAC merger that will infuse it with $276 million.

FDA rejection of rare disease drug leads Orphazyme to cut two thirds of staff

Orphazyme’s corporate restructuring comes less than two weeks after the FDA rejected arimoclomal, a drug developed to treat the rare Niemann-Pick disease type C. The company said it is now focused on securing regulatory approval in Europe and finding a path forward for the small molecule with the FDA.

Intellia’s early CRISPR trial data validate a drug pipeline and the gene-editing field

Intellia Therapeutics has early clinical trial data showing that its CRISPR-based therapy for a rare disease can edit genes inside the body safely and effectively. The trial is ongoing, but the preliminary results suggest that Intellia’s approach could offer a cure.

INVEST Pitch Perfect winner spotlight: Systems Oncology’s AI tech yields trove of cancer drugs

Systems Oncology has used its its artificial intelligence to discover small molecules in development under partnerships with large pharma companies. The R&D of the company, the biopharma startup winner in the Pitch Perfect contest at the recent MedCity News INVEST Conference, includes a new type of RNA drug.

Health Union Acquires WEGO Health

Health Union, the leader in building online health solutions for people living with chronic conditions, today announced that it has acquired WEGO Health, the world’s largest network of patient leaders – advocates, community leaders, creators and influencers. Combining Health Union’s targeted scale and depth in the condition experience with WEGO Health’s breadth of patient leaders …

Health Union Acquires WEGO Health Read More »

CytoReason Collaborates with Sanofi to Initiate its Project Utilizing AI Technology for Asthma

Shots: CytoReason reports the initiation of a project with Sanofi by utilizing its cell-centered models and deconvolution techniques to counsel mechanistic insights for each asthma endotype The focus of the project is to drive a better understanding of heterogeneity in asthma patients and identify stable and reproducible asthma endotypes alongwith associated diagnostic features by using …

CytoReason Collaborates with Sanofi to Initiate its Project Utilizing AI Technology for Asthma Read More »

Lyell, Verve IPOs raise a combined $692M as both biotechs steer toward clinical trials

Lyell Immunopharma and Verve Therapeutics are still preclinical, but they’re bring novel genetic approaches to the treatment of cancer and cardiovascular disease. Now the two companies can claim two of the biggest biotech IPOs of 2021 so far.

Atea Pharma Secures $50M Milestone Payment with Roche in the Development of AT-527 for COVID-19

Shots: Atea Pharma achieved a milestone related to the development of AT-527 and is expecting to receive a related payment of $50M under its license agreement with Roche. The company believes that AT-527 is suitable for use in both pre-and post-exposure prophylactic settings and complementary to vaccines The companies are jointly developing AT-527 for the …

Atea Pharma Secures $50M Milestone Payment with Roche in the Development of AT-527 for COVID-19 Read More »

RxLightning raises $3M to help providers streamline specialty drug enrollment

The health technology company offers a platform that enables clinicians to more quickly and accurately complete specialty drug enrollment processes and communicate with specialty pharmacies. The goal is to simplify the administrative burden on providers and get patients quicker access to the medications they need.

Linnaeus Therapeutics Reports the Expansion of Clinical Collaboration with Merck to Evaluate LNS8801 + Keytruda for the Treatment of Patients with Advanced Cancer

Shots: Linnaeus will conduct 6 additional P-II cohorts evaluating LNS8801 + Keytruda in several cancer indications while the companies are currently evaluating the combination in patients who had previously responded to PD-1/L1 therapy and also LNS8801 as a monothx in patients unable to tolerate PD-1/L1 therapy due to serious immune-related AEs The companies will further …

Linnaeus Therapeutics Reports the Expansion of Clinical Collaboration with Merck to Evaluate LNS8801 + Keytruda for the Treatment of Patients with Advanced Cancer Read More »

While Sage Therapeutics sees a window for depression drug, market is skeptical

A Sage Therapeutics depression drug that failed a pivotal study in 2019 has positive preliminary results from a new Phase 3 clinical trial, but the data also showed the therapy’s effects waned over time. Questions about zuranolone’s durability are relevant to Biogen, which committed $1.5 billion to Sage in large part due to the drug’s …

While Sage Therapeutics sees a window for depression drug, market is skeptical Read More »

GSK joins chase for hot cancer target, paying iTeos $625M in new alliance

GlaxoSmithKline is paying iTeos Therapeutics $625 million up front to share in the development of an antibody that targets the TIGIT protein, a hot target in cancer immunotherapy R&D. The deal comes less than a month after rival Bristol Myers Squibb inked its own deal securing rights to a TIGIT-targeting Agenus drug.

Novavax Covid-19 vaccine shows 90% efficacy, protection against variants

Novavax reported that its Covid-19 vaccine was 100% effective at protecting against moderate and severe disease and 90.4% effective overall. The vaccine is seen as an important alternative to messenger RNA vaccines because of its storage and distribution advantages.

ASCO 2021 recap: Lynparza’s lift, Grail goes on, LAG validation & more

The American Society of Clinical Oncology’ annual meeting featured news highlights from the Merck, Novartis, and other drug giants. Meanwhile, some small biotechs rode the coattails of their larger counterparts and others forged their own paths with promising early results for new cancer drug targets.

Verona Pharma Signs $219M Agreement with Nuance Pharma to Develop and Commercialize Ensifentrine in Greater China

Shots: Verona Pharma to receive $40M including $25M upfront cash and $15M equity interest in Nuance Biotech, and is eligible to receive ~$179M in milestones along with royalties on net sales in Greater China (mainland China, Taiwan, Hong Kong and Macau) Verona Pharma granted Nuance Pharma exclusive right to develop & commercialize ensifentrine in Greater …

Verona Pharma Signs $219M Agreement with Nuance Pharma to Develop and Commercialize Ensifentrine in Greater China 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 »

Pioneering a new realm of biology, startup Senda Bio expands financing to $98M

Senda Biosciences is developing drugs based on an understanding of intersystems biology—the way that humans interact with bacteria and plants. The startup, founded by Flagship Pioneering, has added $55 million to advance its three lead programs to clinical testing next year.

Clinical trials are undergoing a sea change thanks to telehealth, advanced data solutions

The clinical trial arena is changing rapidly, driven largely by the acceleration of telehealth usage and the potential provided by new data solutions. Panelists at MedCity INVEST Precision Medicine agreed that clinical trials will never be conducted in the same way again.

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 »

Merck Signs ~$1.2B Supply Agreement with US Government for Molnupiravir to Treat COVID-19

Shots: Merck to receive ~$1.2B to supply ~1.7M courses of molnupiravir to the US government, if its receives EUA or approval from the US FDA and expects to have 10M+ courses of therapy available by the end of 2021 The therapy is currently being evaluated in a P-III MOVe-OUT study in non-hospitalized patients with COVID-19. …

Merck Signs ~$1.2B Supply Agreement with US Government for Molnupiravir to Treat COVID-19 Read More »

Cancer doc: To boost minority participation, we have fliers in our clinic saying “Ask me about a clinical trial”

Minority groups get left out of clinical trials and studies for many reasons, including lack of access, awareness and trust in the healthcare system. But, according to panelists at MedCity INVEST Precision Medicine, researchers along with patient advocates can help tackle these hurdles by working together and being intentional in their approach.

Pfizer’s Prevnar 20 wins FDA nod, getting edge in pneumococcus vax race—for now

The FDA has approved Prevnar 20, a Pfizer vaccine that protects against 20 pneumococcal strains—seven more than the company’s blockbuster Prevnar 13. But others are on Pfizer’s heels with vaccine candidates that aim to match or even beat the Pfizer pneumococcal vaccines.

Janssen Discontinue its 2018 License Agreement with Argenx for Cusatuzumab

Shots: The discontinuation is based on Janssen’s review of all available cusatuzumab data and in consideration of the evolving SOC for AML. Argenx regain its WW rights to cusatuzumab from Cilag The P-Ib ELEVATE interim data will support the development of the anti-CD70 Ab in AML, whereas argenx plans to evaluate options to enable a …

Janssen Discontinue its 2018 License Agreement with Argenx for Cusatuzumab Read More »

Merus eyes tumor-agnostic path for cancer drug addressing rare genetic target

Cancer drug developer Merus has encouraging early results indicating its drug can address several different types of tumors characterized by NRG1, a rare gene fusion. The company believes the data could support a regulatory filing for the bispecific antibody drug.

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 »

Versant Ventures unveils new startup that stabilizes proteins to treat disease

Stablix Therapeutics is developing technology that uses small molecules to stabilize a protein, keeping it from going to a cell’s built-in disposal system. The startup now has $63 million in funding to further invest in the technology and advance its first molecules toward the clinic.

FDA authorizes Regeneron’s Covid drug at lower dose, and in injectable formulation

Emergency authorization of Regeneron Pharmaceuticals’ Covid-19 antibody drug now includes an injectable version, which is a more convenient option for patients. The drug developer plans to seek full FDA approval of its antibody cocktail later this summer.

Pharma Supply Chain Conference Virtual

Join us for an interactive, one-day digital event, where VPs, Directors and Heads of Supply Chain and Logistics come together to share their experiences, brainstorm challenges and take advantage of new opportunities in the global pharma supply chain industry. Helping you transform, redefine and innovate your supply chain strategy during these unprecedented times and beyond. …

Pharma Supply Chain Conference Virtual 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 »

United Therapeutics Reports the First Patient Enrollment in P-III TETON Study of Tyvaso for Idiopathic Pulmonary Fibrosis

Shots: The first patient has enrolled in P-III TETON study to evaluate the safety and efficacy of treprostinil (Inhalation Solution) or PBO in a ratio (1:1) in 396 adult patients with IPF The 1EPs of the study is the change in FVC from baseline@ 52 wks. and 2EPs include time to clinical worsening, time to …

United Therapeutics Reports the First Patient Enrollment in P-III TETON Study of Tyvaso for Idiopathic Pulmonary Fibrosis Read More »

Novartis radiopharmaceutical improves survival in key prostate cancer study

Novartis reported Phase 3 study results for a targeted radiation therapy showing that treatment helped patients with advanced prostate cancer live longer. The company will present data from this pivotal study during the annual meeting of the American Society of Clinical Oncology.

Auris Medical pivots from hearing loss drugs, joins red hot RNA therapies field

Auris Medical has acquired Trasir Therapeutics, a startup developing technology that expands the delivery of RNA medicines to tissues beyond the liver. Going forward, Auris will sell or spin off its programs in hearing disorders and allergies and focus exclusively on RNA therapies.

MorphoSys to buy Constellation Pharma in a $1.7B bet on epigenetic cancer drugs

MorphoSys is acquiring Constellation Pharmaceuticals and its late-stage myelofibrosis drug in a deal that values the epigenetics biotech at $1.7 billion. Germany-based MorphoSys will finance the acquisition with cash from a separate $2 billion deal with drug royalty acquirer Royalty Pharma.

PM Society Training: Essentials of Pharmaceutical Marketing

Who will benefit? New and aspiring marketers and those wanting to refresh their marketing thinking and be fitter to handle today’s healthcare environment. Topics covered Overview of pharmaceutical marketing Pharmaceutical marketing strategy concepts and tools Effective market and competitor analysis Increasing impact through effective segmentation & targeting Building competitive advantage through creative product positioning The …

PM Society Training: Essentials of Pharmaceutical Marketing Read More »

Eying eczema, Amgen pays $400M to co-develop Phase 3-ready Kyowa Kirin drug

Amgen is paying Kyowa Kirin $400 million to share in the development of a drug that could offer a new approach to treating atopic dermatitis, a form of eczema. The deal comes months after Japan-based Kyowa Kirin reported positive preliminary Phase 2 data for its antibody.

Bouncing back from FDA rejection, Alkermes psychiatric drug wins approval

Alkermes antipsychotic drug Lybalvi now has FDA approval. Though the field of neuropsychiatric drugs is crowded with generic medications, Alkermes believes Lybalvi, designed to mitigate the weight gain side effect common with mood disorder drugs, could have an advantage.

Amgen and Kyowa Kirin Collaborate to Develop and Commercialize KHK4083 for Atopic Dermatitis

Shots: Kyowa Kirin to receive ~$400M up front and an additional ~$850M as milestones along with royalties on future global sales. Both companies will share global development costs (Ex- Japan & the US) Amgen will responsible for the development, manufacturing, and commercialization of KHK4083 for all markets globally (Ex-Japan, where Kyowa Kirin will retain all …

Amgen and Kyowa Kirin Collaborate to Develop and Commercialize KHK4083 for Atopic Dermatitis Read More »

Amgen lands first FDA approval for drug targeting elusive mutation in lung cancer

FDA approval of Amgen drug sotorasib (Lumakras) makes the small molecule the first compound authorized by the regulator for treating cancers characterized by a KRAS G12C mutation. Mutated KRAS proteins had long been regarded “undruggable” targets.

FDA authorizes Vir & GSK Covid-19 drug, introducing third antibody option

FDA authorization of the Covid-19 antibody drug from Vir Biotechnology and GlaxoSmithKline adds a third antibody drug for treating early cases of the disease that are at risk of progressing to hospitalization. The companies say they plan to launch the drug, named sotrovimab, “in coming weeks.”

FDA places clinical hold on Larimar’s rare disease drug after deaths in monkey study

The FDA placed a clinical hold on a Larimar Therapeutics program for Friedreich’s ataxia after monkeys died in tests of the fusion protein. In addition to halting further tests of the drug, the clinical hold also ends the biotech’s plan to raise $95 million that would have funded clinical research.

Partnerships in pharma: exploring intersections across molecules and software

Earlier this year, Healthware Group and Plexus Ventures formed an alliance to structure deals for the pharmaceutical industry in the development and commercialization of Digital Therapeutic (DTx) products. Given the increased attention and growth seen in the market, both companies are leveraging their expertise to become go-to partners for life sciences companies looking to incorporate DTx into their pipelines. Healthware …

Partnerships in pharma: exploring intersections across molecules and software Read More »

IQVIA adds to growing lab biz with $198M deal for Myriad contract services unit

IQVIA is paying nearly $200 million to purchase a Myriad Genetics subsidiary that provides pharmaceutical contract services , a deal that will put the new acquisition in the company’s Q2 Solutions unit, The deal follows IQVIA’s April announcement that it had secured full ownership of Q2, which had been a joint venture with Quest Diagnostics.

Moderna’s Covid vaccine shows efficacy in younger teens; regulatory filing are next

Moderna released preliminary clinical data showing its Covid-19 vaccine produced efficacy in adolescents that was comparable to what was seen in adults. The company plans to submit applications to regulators in early June seeking expansion of emergency authorization of the vaccine to include this younger age group.

COVID jab rollout provides short opportunity for pharma to build trust

After decades of struggling with poor public perception, the pharma industry has an opportunity to generate stronger connections with consumers than ever thanks to the COVID-19 vaccine drive – but it will have to move quickly.  That is the conclusion of a Mediahub study which cites recent poll data in the US giving the industry …

COVID jab rollout provides short opportunity for pharma to build trust Read More »

NGM Bio’s NASH drug fails in Phase 2; focus shifts to Merck-partnered programs

An NGM Biopharmaceuticals drug candidate for the fatty liver disease NASH failed a Phase 2b study less than a year after the company reported positive results from an earlier mid-stage study. The biotech will now focus on programs in eye diseases and cancer that are partnered with Merck.

FDA approval of J&J drug is first for lung cancer with particular genetic mutation

Johnson & Johnson subsidiary Janssen was awarded approval for Rybrevant, the latest in a string of decisions for targeted therapies for non-small cell lung cancer. Rybrevant is the first approved targeted therapy addressing a subset of patients whose disease is characterized by a particular mutation to cancer protein EGFR.

CVS joins the decentralized clinical trials movement with launch of new biz unit

CVS has launched a new clinical trials services business that will help drug companies and contract research organizations recruit clinical trial volunteers. The new business unit builds on work the pharmacy giant did last year, identifying and recruiting recruit people for clinical trials testing Covid-vaccines and medicines.

Biogen teams up with Ginkgo Bioworks in gene therapy manufacturing pact

Biogen is reaching across the Charles River, striking up a gene therapy manufacturing alliance with synthetic biology firm Ginkgo Bioworks. Ginkgo will use its technology to accelerate and make more efficient the process of manufacturing the AAV viral vectors used in gene therapies.

Eli Lilly looks ahead to FDA after diabetes drug wraps up last clinical test

Eli Lilly diabetes drug tirzepatide beat long-acting insulin in the last of a series of global studies designed to support regulatory submissions for the type 2 diabetes drug, a potential successor to blockbuster drug Trulicity. The Indianapolis-based drug giant said it expects to file for approval by the end of 2021.

Bristol Myers “dual immunotherapy” beats Opdivo alone in melanoma study

Bristol Myers Squibb reported Phase 3 data that show its experimental cancer immunotherapy relatlimab, combined with the company’s blockbuster drug Opdivo, was better at stopping melanoma from progressing. BMS will present the data at the upcoming annual meeting of the American Society of Clinical Oncology.

Bayer’s BlueRock Therapeutics widens cell therapy scope to the eye under new pact

BlueRock Therapeutics, a Bayer subsidiary, is teaming up with Opsis Therapeutics and Fujifilm Cellular Dynamics in an R&D pact focused on developing stem cell therapies for eye diseases. BlueRock is paying its new partners $30 million up front to kick off the alliance.

BMS Extends its 2019 Collaboration with Exscientia for AI Driven Drug Discovery

Shots: Exscientia to receive ~$50M as up front, ~$125M as milestones and additional clinical, regulatory, and commercial milestones of over $1.2B along with royalties on net sales of any marketed therapies resulting from the collaboration The expanded collaboration has the potential to add to the BMS drug pipeline whilst enhancing Exscientia’s portfolio of shared assets. …

BMS Extends its 2019 Collaboration with Exscientia for AI Driven Drug Discovery Read More »

Janssen Signs an Option and License Agreement with Mestag to Discover Novel Fibroblast Targets for Inflammatory Disease

Shots: Mestag to receive option fees, milestones, royalties and will deploy its specialist fibroblast sub-population biology platform and state-of-the-art data analytics to identify novel therapeutic targets Janssen to get an option to exclusive license to develop and commercialize therapies directed against up to two targets emerges from the collaboration Apart form this collaboration, Mestag will …

Janssen Signs an Option and License Agreement with Mestag to Discover Novel Fibroblast Targets for Inflammatory Disease Read More »

Bristol Myers writes $200M check for rights to Agenus checkpoint inhibitor

Bristol Myers Squibb already has a cancer program targeting the TIGIT protein, but in acquiring rights to Agenus’s drug, the pharma giant adds a bispecific antibody that preclinical research suggests has the potential to be the best in this drug class. BMS agreed to pay $200 million up front for global rights.

BlueRock Collaborates with Fujifilm and Opsis to Discover and Develop Cell Therapies for Eye Diseases

Shots: Fujifilm and Opsis to receive $30M up front and ~$40M as R&D and part of manufacturing funding for the development of 3 programs. The companies are eligible to receive development & commercial milestones along with royalties on a per-program basis BlueRock to get an option to license the 3 programs on a program-by-program basis …

BlueRock Collaborates with Fujifilm and Opsis to Discover and Develop Cell Therapies for Eye Diseases Read More »

With FDA approval, Apellis can challenge AstraZeneca in rare blood disorder

The FDA approved Apellis Pharmaceuticals drug pegcetacoplan (Empaveli) as a treatment for a rare blood disorder that is currently treated with medicines sold by Alexion Pharmaceuticals, a biotech being acquired by AstraZeneca. But Apellis’s drug beat Alexion drug Soliris in a head-to-head test, and the smaller company aims to steal market share from its larger …

With FDA approval, Apellis can challenge AstraZeneca in rare blood disorder Read More »

Sanofi & GSK Covid-19 vaccine posts strong clinical data, paves way for Phase 3

Sanofi and GlaxoSmithKline reported positive preliminary Phase 2 data for their Covid-19 vaccine. Though several vaccines have been authorized, the companies say that their vaccine’s foundation in existing influenza vaccines offers advantages, and potentially gives their candidate a place in the market as a booster shot.

Wall Street is lukewarm to Vera’s pivot from gene editing to rare kidney disease

Vera Therapeutics raised $47.9 million from its IPO to continue clinical development of its lead asset, a potential treatment for the kidney disease IgA nephropathy. But the company is joining a crowded field of companies aiming to develop a drug for the rare disorder.

GoodRx leadership downplays Amazon Pharmacy worries despite lackluster stock price

In a month where GoodRx’s stock has been trading below IPO levels, the startup’s leadership says Amazon Pharmacy still isn’t a threat. Citing third-party data, the company said uptake of Amazon’s pharmacy services have been low, though the retailer still could pose a threat with its growing healthcare business.

AzurRx BioPharma Reports Positive Interim P-II Data of MS1819 + PERT for Cystic Fibrosis Patients with Severe Exocrine Pancreatic Insufficiency

Shots: The interim data from 18 patients out of 20 in P-II trial evaluating the safety, tolerability, and efficacy of MS1819 (700/1200/2240 mg, qd, for 15 days/dosing level) + PERT aged 12 yrs or older in CF patients for EPI The 1EP & 2EP of the trial demonstrated improvement in CFA, improvement in stool weight, …

AzurRx BioPharma Reports Positive Interim P-II Data of MS1819 + PERT for Cystic Fibrosis Patients with Severe Exocrine Pancreatic Insufficiency Read More »

Backed by $92M, startup Interline aims to shed new light on protein communities

Interline Therapeutics has technology that shows how proteins interact as communities, paving the way for the discovery of new drugs. CEO Zachary Sweeney, a Denali Therapeutics veteran, said the startup will use the $92 million in funding to advance programs in cancer and inflammatory diseases.

Heron Therapeutics’ combo drug for post-surgical pain wins FDA nod on third try

Heron Therapeutics is positioning its drug, Zynrelef, as a way to help patients avoid addictive opioid painkillers following surgery. The extended-release formulation offers analgesic effects over 72 hours—when postsurgical pain is most severe and more likely to require pain management medication.

Biogen Exercises its Option to Acquire TMS-007 for Acute Ischemic Stroke

Shots: Biogen’s decision of acquisition of TMS-007 based on the safety, imaging, and clinical outcome data from the P-IIa study which showed positive impacts on both blood vessel reopening in the brain, as well as patient functional recovery with no incidence of sICH TMS to receive $18M upon acquisition of TMS-007 and is eligible to …

Biogen Exercises its Option to Acquire TMS-007 for Acute Ischemic Stroke Read More »

Biogen adds to neuro drug pipeline with acquisition of stroke drug from TMS

Biogen paid $18 million to acquire a drug that TMS Co. of Japan tested in patients with acute ischemic stroke. The acquisition follows the report of preliminary mid-stage data showing the drug led to no cases of a potentially fatal complication associated with currently available stroke therapies.

Perceptive Advisors closes $515M fund to fuel more early-stage biotech startups

Perceptive Advisors has $515 million for its second fund investing in biotech startups. Portfolio Manager Chris Garabedian says Perceptive Xontogeny Ventures Fund II is looking to make Series A investments in early-stage companies with assets that can show a path to clinical testing.

Nanobiotix Collaborates with Lianbio to Develop and Commercialize NBTXR3 in China and other Asian Countries

Shots: Nanobiotix to receive a $20M up front and is eligible to receive ~$220 M as contingent payments and milestones along with royalties on net sales of NBTXR3 in the licensed countries LianBio to get exclusive rights to develop and commercialize NBTXR3 in Greater China, South Korea, Singapore, and Thailand LianBio supports the expansion of …

Nanobiotix Collaborates with Lianbio to Develop and Commercialize NBTXR3 in China and other Asian Countries Read More »

Autobahn Acquires Global Rights to Astellas’ ASP3652 to Bolster its Brain Targeting Chemistry Platform

Shots: Autobahn acquires global IP, development, and regulatory rights to ASP3652 to strengthen its brain-targeting chemistry platform. The addition of ASP3652 will accelerate the delivery of next-generation brain-targeting prodrugs for CNS disorders, particularly MS ASP3652 complements Autobahn’s brain-targeting chemistry platform, which uses FAAH-mediated prodrug conversion to enable the delivery of small molecules across the BBB. …

Autobahn Acquires Global Rights to Astellas’ ASP3652 to Bolster its Brain Targeting Chemistry Platform Read More »

J&J, Village Capital unveil 12 startups building culturally competent care in new accelerator

The companies are supporting 12 culturally competent healthcare startups in a new accelerator. Two of them will get up to $200,000 in grant funding. 

Talaris Therapeutics’ IPO raises $150M to transform solid organ transplants

Three biotechs IPOs priced this week while one gene therapy developer postponed its plans. The biggest IPO belongs to Talaris Therapeutics, a company developing a cell therapy for organ transplant patients that could mean the end of lifelong immunosuppressive drugs that prevent rejection.

Merck and Fusion Pharmaceuticals Enter into a Clinical Collaboration for FPI-1434 + Keytruda (pembrolizumab) to Treat Solid Tumors Expressing IGF-1R

Shots: The collaboration will evaluate Fusion’s FPI-1434 + Merck’s Keytruda in patients with solid tumors expressing IGF-1R. Fusion will sponsor the study and Merck will supply Keytruda The companies plan to initiate a P-I/II trial to evaluate the safety, tolerability, and PK of combination therapy and is expected in ~6 to 9 mos. upon achieving …

Merck and Fusion Pharmaceuticals Enter into a Clinical Collaboration for FPI-1434 + Keytruda (pembrolizumab) to Treat Solid Tumors Expressing IGF-1R Read More »

BeiGene and Asieris Enter into Clinical Collaboration for APL-1202 + Tislelizumab to Treat Muscle Invasive Bladder Cancer

Shots: BeiGene and Asieris collaborate to evaluate the safety and efficacy of APL-1202 + tislelizumab as neoadjuvant therapy in patients with MIBC. APL-1202 has been approved to treat patients with locally advanced or metastatic UC and high expression of PD-L1 who failed to receive platinum-based CT Asieris plans to submit INDs in China and the …

BeiGene and Asieris Enter into Clinical Collaboration for APL-1202 + Tislelizumab to Treat Muscle Invasive Bladder Cancer Read More »

Andreessen Horowitz leads $100M Series A round in Dyno and its gene therapy tech

Dyno Therapeutics’ technology for designing viral vectors that deliver gene therapies has led to partnerships with Novartis, Sarepta Therapeutics, and Roche. With the Series A financing, the startup plans to expand its technology to address more tissue types, and potentially add more partners.

ProQR Therapeutics Signs an Exclusive Worldwide License Agreement with Yarrow to Develop Therapies for Non-Ophthalmic Target

Shots: ProQR is eligible to receive ~$115M up front and milestone along with royalties on the sales of any resulting products during the royalty term and gets the right to receive a percentage of equity in the form of Yarrow shares Yarrow has in-licensed exclusive rights for ProQR’s ASO technology to develop and commercialize potential …

ProQR Therapeutics Signs an Exclusive Worldwide License Agreement with Yarrow to Develop Therapies for Non-Ophthalmic Target Read More »

Formedix Expedites Clinical Trial Build with New Cloud Clinical MDR Suite

Glasgow, UK – (March 29, 2021) – Formedix, a leading provider of clinical trial software solutions, announces the launch of ryze, an innovative all-in-one cloud-based clinical metadata repository (MDR) and study automation platform. ryze has been specifically developed to accelerate and streamline the design, build and submission of clinical trials, in compliance with the Clinical …

Formedix Expedites Clinical Trial Build with New Cloud Clinical MDR Suite Read More »

Roivant’s move to go public reveals just how much its drug strategy has changed

Founded by former hedge fund manager Vivek Ramawamy, Roivant Sciences set out to redefine drug development by acquiring overlooked drugs and advancing their development. The merger deal that will take it public reveals how much new technology changed the company’s vision and its strategy.

Biotech IPO wave rolls on as Werewolf, Vaccitech raise $230M for clinical trials

Vaccitech and Werewolf Therapeutics joined the public markets, raising a combined $230 million. The vaccine developer and the cancer immunotherapy biotech will apply the IPO proceeds toward clinical development of their respective pipelines.

Two new biotechs unveil $112M combined for antibody drug conjugates for cancer

The list of FDA-approved antibody drug conjugates (ADC) is growing, and two more biotech startups have emerged from stealth with new cash and new approaches to this type of cancer drug. Adcendo and Adcentrx raised a combined $112 from their Series A financings.

Adverum Bio’s shares plummet after patient in gene therapy study loses vision

Adverum Biotechnologies reported that a diabetic macular edema patient treated with the biotech’s experimental gene therapy developed complications, including blindness, in the treated eye. The company has unmasked the study and is trying to identify potential risks to other patients.

3 Considerations for Pharma Brand Strategy Success

Change is coming in the digital marketing world whether you’re ready or not. New challenges are presented for marketers as privacy measures tighten and we say goodbye to cookies, yet this impending farewell also presents an invaluable opportunity to rejuvenate your pharma brand strategy. As healthcare marketers prepare for the switch to flip, one thing is …

3 Considerations for Pharma Brand Strategy Success Read More »

Startup Boundless Bio brings in $105M to break the circle behind cancer growth

Boundless Bio’s research has uncovered a previously unknown driver of cancer growth and drug resistance. With $105 million in Series B financing, the biotech is on a path to bring to the clinic small molecules that address this target, called extrachromosomal DNA.

No more tears: Aldeyra’s eye drug data support its allergy treatment alternative

Seasonal allergy sufferers have a plethora of choices for treating the itching and redness affecting their eyes. An experimental Aldeyra Therapeutics drug that takes a new approach to blocking inflammation triggered by allergens has met the goals of a pivotal study and the biotech now plans to discuss the data with the FDA.

Daiichi Sankyo Expands its Collaboration with Esperion to Additional Territories

Shots: Esperion to receive $30M up front, ~$175M as sales milestones along with royalties from 5-20% on sales in the territory. Daiichi Sankyo will get exclusive commercialization rights to bempedoic acid and bempedoic acid/ezetimibe combination tablet in S. Korea, Taiwan, Hong Kong, Thailand, Vietnam, Brazil, Macao, Cambodia, and Myanmar The agreement allows for the expansion …

Daiichi Sankyo Expands its Collaboration with Esperion to Additional Territories Read More »

FDA lifts clinical hold, clearing uniQure to resume hemophilia gene therapy trial

A uniQure gene therapy for hemophilia B that has been under a clinical hold for four months can now resume testing. The hold was lifted after uniQure answered the FDA’s questions about whether the gene therapy caused the liver cancer diagnosed in one patient who received the therapy.