Pharma

Jazz Pharmaceuticals Acquires SpringWorks’ FAAH Inhibitor Program for Post-Traumatic Stress Disorder

  • by

Shots: SpringWorks to receive $35M as upfront and $ 375M as clinical, regulatory, and commercial milestones and is eligible to receive royalties on future net sales of PF-04457845. Jazz to get an exclusive license of all assets relating to the FAAH inhibitor program including PF-04457845… Read More »Jazz Pharmaceuticals Acquires SpringWorks’ FAAH Inhibitor Program for Post-Traumatic Stress Disorder

Bayer paying up to $4B for gene therapy pioneer AskBio

  • by

The deal, offering $2 billion up front and $2 billion in future milestone payments, includes a gene therapy manufacturing facility and a pipeline that includes treatments for Parkinson’s and congestive heart failure.

Samsung Biologics Collaborates with Dinona to Develop DNP-019 for COVID-19

  • by

Shots: The companies collaborate for fast-track development of DNP-019 against COVID-19 The collaboration will expand Samsung’s CDO capabilities to provide a full scope of its development services from cell line development, process development, to non-clinical and clinical material manufacturing Samsung has introduced its proprietary cell-line… Read More »Samsung Biologics Collaborates with Dinona to Develop DNP-019 for COVID-19

ImmunoGen Signs an Agreement with Huadong to Develop & Commercialize Mirvetuximab Soravtansine in Greater China

  • by

Shots: ImmunoGen to receive $40M up front, ~$265M as development, regulatory & commercial milestones and is eligible to receive royalties on sales of mirvetuximab in Greater China and will retain all rights to mirvetuximab in the US & ROW The collaboration accelerates the development path… Read More »ImmunoGen Signs an Agreement with Huadong to Develop & Commercialize Mirvetuximab Soravtansine in Greater China

Takeda Signs ~$1B Pact with Arrowhead for ARO-AAT Targeting Alpha-1 Antitrypsin-Associated Liver Disease

  • by

Shots: Arrowhead to receive ~$300M up front, ~$740M as development, regulatory and commercial milestones and is eligible to receive royalties of 20-25% on net sales If approved, the companies will co-develop ARO-AAT and co-commercialize it in the US, under 50/50 profit sharing structure. Additionally, Takeda… Read More »Takeda Signs ~$1B Pact with Arrowhead for ARO-AAT Targeting Alpha-1 Antitrypsin-Associated Liver Disease

The COVID-19 Effect: How Pharma Can Adapt to the Evolving Patient Experience

  • by

Patient experiences are evolving. How can pharma keep up?By listening to the people who are navigating this new landscape everyday. Integrating personal experiences and patient-reported data, this one-day virtual event features real-time conversations between people living with chronic conditions and Health Union industry experts. Tune in to any… Read More »The COVID-19 Effect: How Pharma Can Adapt to the Evolving Patient Experience

Pfizer Signs an Agreement with SpringWorks to Evaluate Nirogacestat + PF‐06863135 for R/R Multiple Myeloma

  • by

Shots:   Pfizer to sponsor & conduct P-Ib/II study evaluating the safety, tolerability, and preliminary efficacy of dual regimen and will assume costs of study & other expenses related to IP rights.  The companies will form a joint development committee to manage clinical study which is… Read More »Pfizer Signs an Agreement with SpringWorks to Evaluate Nirogacestat + PF‐06863135 for R/R Multiple Myeloma

KOL Validation

  • by

A significant proportion of the clients we work with know that KOLs well. They also recognise that this in itself is the problem!   When you have been in a therapy area for a while and have done your KOL identification and KOL mapping previously,… Read More »KOL Validation

Anthem Expands Relationship with doc.ai to Power Digital Health Offerings

  • by

What You Should Know: – Anthem extends the use of doc.ai’s platform and portfolio of privacy-first technologies and artificial intelligence software services to drive the personalization of Anthem’s digital assets and create improved value for users. – doc.ai’s product offerings are deployed on its cloud-agnostic… Read More »Anthem Expands Relationship with doc.ai to Power Digital Health Offerings

Are there any pharma companies that offer 100% tuition reimbursement if one pursues part-time school while working?

  • by

Follow-up question: – Any pharmas that encourage joint working-PhD programs that aren’t insanely competitive/impossible to get into? I currently work at Pfizer, they offer $10k tuition reimbursement per year. For me, this means 2 master’s classes per year… which = 5 years for my master’s.… Read More »Are there any pharma companies that offer 100% tuition reimbursement if one pursues part-time school while working?

Value of Research

  • by

Hello guys I just want to know what are your insights and opinion about the Value of Research and development in this time of pandemic ? submitted by /u/tala027 [link] [comments]

GoodRx files to go public

  • by

GoodRx, a digital health startup that helps users track prescription drug prices, filed for an IPO on Friday. The company hasn’t yet priced its shares, but plans to be listed on Nasdaq as “GDRX.”

Bayer Reports the NDA Submission to NMPA for Vericiguat to Treat Chronic Heart Failure in China

  • by

Shots: The NDA submission was submitted to NMPA’s CDE and is based on P-III VICTORIA study, seeking regulatory approval of vericiguat in China In Oct’2014, Bayer and MSD signed a WW agreement for sGC modulators. The therapy is being jointly developed by both the companies… Read More »Bayer Reports the NDA Submission to NMPA for Vericiguat to Treat Chronic Heart Failure in China

Galecto’s GB0139 Receives the US FDA’s and EMA’s Orphan Drug Designations for Idiopathic Pulmonary Fibrosis

  • by

Shots: The US FDA and EMA has received ODD to Galecto’s GB0139 for the treatment of IPF. GB0139 showed significant reduction of YKL-40 biomarker in fibrosis, inflammation, tissue remodeling diseases in its first clinical study after 14 days of treatment The EMA cited GB0139’s clinically… Read More »Galecto’s GB0139 Receives the US FDA’s and EMA’s Orphan Drug Designations for Idiopathic Pulmonary Fibrosis

AbbVie and Harvard University Collaborate to Develop Novel Therapies Against Emergent Viral Diseases

  • by

Shots: AbbVie and Harvard University enter a $30M research alliance to study & develop novel therapies against emergent viral infections with an initial focus on coronavirus and the viruses leading to hemorrhagic fever The focus of the collaboration is to integrate fundamental biology into the… Read More »AbbVie and Harvard University Collaborate to Develop Novel Therapies Against Emergent Viral Diseases

AbbVie Exercises its Option to License Morphosys’ αvβ6 Integrin Inhibitor Program for Fibrotic Disease

  • by

Shots: Morphic will receive a $20M as license fee and is eligible to receive milestones and royalties on sales of any commercialized therapy while AbbVie has exercised a license option under the companies’ R&D collaboration agreement to develop Morphic’s αvβ6 integrin inhibitors for fibrotic diseases… Read More »AbbVie Exercises its Option to License Morphosys’ αvβ6 Integrin Inhibitor Program for Fibrotic Disease

Exclusive interview with ForwardVue Pharma released for Ophthalmic Drugs 2020

  • by

SMi reports: Alan Franklin, CEO, ForwardVue Pharma will be presenting at the Ophthalmic Drugs conference The 4th Annual Ophthalmic Drugs Conference taking place on the 23rd -24th November 2020, will explore new discoveries in the treatment of ocular disease, innovations in combination technologies, and the… Read More »Exclusive interview with ForwardVue Pharma released for Ophthalmic Drugs 2020

AstraZeneca Collaborates with RenalytixAI to Develop Precision Medicine for Chronic Diseases

  • by

Shots: The two companies will develop and launch precision medicine strategies for CV, renal, and metabolic diseases. The first stage in the collaboration will use KidneyIntelX to improve outcomes for patients with CKD and its complications, in coordination with the Mount Sinai Health System The… Read More »AstraZeneca Collaborates with RenalytixAI to Develop Precision Medicine for Chronic Diseases

BioMarin Reports NDA Submission to the US FDA for Vosoritide to Treat Children with Achondroplasia

  • by

Shots: BioMarin has submitted an NDA to the US FDA for vosoritide to treat children with achondroplasia The company also reported that EMA has begun validation of MAA for the therapy on 13 Aug, 2020 Vosoritide is an investigational, once-daily injection analog of C-type Natriuretic… Read More »BioMarin Reports NDA Submission to the US FDA for Vosoritide to Treat Children with Achondroplasia

Qualitative KOL Mapping

  • by

If you were trying to identify the most influential people within a large and active Facebook group, would you restrict yourself to analysing “number of posts” and other quantitative metrics only?   In such situations, adding a variety of qualitative inputs – to balance the… Read More »Qualitative KOL Mapping

Court approves Otsuka’s bid to buy Proteus for $15M

  • by

A bankruptcy court in Delaware approved a stalking-horse bid from Otsuka to acquire Proteus Digital Health for $15 million. The company, which makes sensor that can be embedded in pills to track medication adherence, filed for bankruptcy in June.

Precision BioSciences Receives the US FDA’s Fast Track Designation for PBCAR0191 to Treat Advanced B-cell Precursor Acute Lymphoblastic Leukemia

  • by

Shots: The US FDA has granted FT designation for PBCAR0191 to treat advanced B-ALL. FT designation facilitates the expedited development and review of a new drug, whether alone or in combination with another drug addressing the unmet medical needs and treats a serious or life-threatening… Read More »Precision BioSciences Receives the US FDA’s Fast Track Designation for PBCAR0191 to Treat Advanced B-cell Precursor Acute Lymphoblastic Leukemia

Roche’s Tecentriq + Bevacizumab Receive Health Canada’s Approval as 1L Treatment for Unresectable or Metastatic Hepatocellular Carcinoma

  • by

Shots: The approval is based on P-III IMbrave150 study assessing Tecentriq (1200 mg) + bevacizumab (15 mg/kg, q3w, IV) vs sorafenib (400mg, bid) in 501 patients in a ratio (2:1) with unresectable or metastatic HCC, prior not treated with systemic therapies Results: 42% reduction in… Read More »Roche’s Tecentriq + Bevacizumab Receive Health Canada’s Approval as 1L Treatment for Unresectable or Metastatic Hepatocellular Carcinoma

Sanofi’s Dupixent (dupilumab) Receives the Health Canada Approval for Severe Chronic Rhinosinusitis with Nasal Polyposis

  • by

Shots: The Health Canada has approved a new indication as an add-on maintenance treatment with intranasal corticosteroids in patients with CRSwNP, inadequately controlled by systemic corticosteroids or surgery The approval is based on P-III studies (24wks. SINUS-24 and 52wks. SINUS-52) assessing Dupixent (300mg, q2w) +… Read More »Sanofi’s Dupixent (dupilumab) Receives the Health Canada Approval for Severe Chronic Rhinosinusitis with Nasal Polyposis

Novo Nordisk Collaborates with Evotec to Develop Therapies Targeting Chronic Kidney Disease

  • by

Shots: Evotec to receive $179M/ product as upfront, research funding and milestones along with the royalties on sales of the therapies while Novo Nordisk will lead the clinical development and commercialization of the therapies The companies will share responsibilities during drug discovery and pre-clinical development… Read More »Novo Nordisk Collaborates with Evotec to Develop Therapies Targeting Chronic Kidney Disease

I put together a blog highlighting 20 Pharma Key Opinion Leaders (KOL). Is this information helpful to the pharmaceutical industry?

  • by

Hi I hope everyone is doing well in these crazy times. Durning my down time i’ve been creating a blog on the top Key Opinion Leaders (KOLs) in the Pharma Industry. The goal was to use the Sunshine Act data to find the most active… Read More »I put together a blog highlighting 20 Pharma Key Opinion Leaders (KOL). Is this information helpful to the pharmaceutical industry?

G1 Therapeutics Reports the US FDA Acceptance and Priority Review of NDA for Trilaciclib to Treat SCLC

  • by

Shots: The NDA submission is based on three clinical studies in which Trilaciclib was administered prior to chemotherapy treatment in patients with SCLC and has demonstrated robust myelopreservation benefits. The company anticipates the PDUFA date as Feb 15, 2021 G1 is making Trilaciclib available to… Read More »G1 Therapeutics Reports the US FDA Acceptance and Priority Review of NDA for Trilaciclib to Treat SCLC

AstraZeneca’s Imfinzi (durvalumab) Receives the US FDA’s Priority Review for Less Frequent Fixed-Dose Use in NSCLC and Bladder Cancer

  • by

Shots: The US FDA has accepted sBLA and granted PR to Imfinzi (1500mg) for a new 4wks. FD regimen to treat patients with unresectable Stage III NSCLC after CT and prior treated advanced bladder cancer, consistent with the approved dosing in ES-SCLC The company anticipates… Read More »AstraZeneca’s Imfinzi (durvalumab) Receives the US FDA’s Priority Review for Less Frequent Fixed-Dose Use in NSCLC and Bladder Cancer

Former KKR Vet Jim Momtazee Launches Healthcare Investment Firm, Patient Square Capital

  • by

Jim Momtazee, Managing Partner at Patient Square Capital What You Should Know: – Former KKR veteran Jim Momtazee announced the launch of Patient Square Capital, a partnership being purpose-built to become the preeminent investment firm in healthcare.  – Patient Square will partner with best-in-class management… Read More »Former KKR Vet Jim Momtazee Launches Healthcare Investment Firm, Patient Square Capital

BMS Signs an Exclusive Worldwide License Agreement with Dragonfly Therapeutics for DF6002

  • by

Shots: Dragonfly to receive $475M as up front and is eligible to receive development, regulatory and commercial milestones in addition to 24% royalties on global sales of the therapy. BMS to get exclusive WW license to Dragonfly’s IL-12 investigational immunotherapy program, including its extended half-life… Read More »BMS Signs an Exclusive Worldwide License Agreement with Dragonfly Therapeutics for DF6002

Swittons Introduces Smart IoT Devices for Pharmaceutical Lab Digital Transformation Initiatives

  • by

Swittons, a P360 company, has announced a new line of Internet of Things (IoT) enabled smart devices built specifically for pharmaceutical labs. The fully customizable devices align with strategic Lab of the Future(LoTF) initiatives and help automate various laboratory workflows between people and existing digital… Read More »Swittons Introduces Smart IoT Devices for Pharmaceutical Lab Digital Transformation Initiatives

Solasia Signs a License Agreement with Isofol to Develop and Commercialize Arfolitixorin for mCRC in Japan

  • by

Shots: Isofol to receive $100M as up front, development, regulatory and commercial milestones, and clinical development cost and is eligible to receive royalties on sales of the therapy and retain its right to the therapy in ROW Solasia will lead clinical development activities in Japan… Read More »Solasia Signs a License Agreement with Isofol to Develop and Commercialize Arfolitixorin for mCRC in Japan

Strata Oncology Collaborates with Mirati Therapeutics to Broaden Enrollment in Clinical Trial of MRTX849 for Patients with Advanced Solid Tumors

  • by

Shots: The multiple expansion cohort will assess the safety, tolerability, drug levels, molecular effects, and clinical activity of MRTX849 in patients with advanced solid tumors harboring a KRAS G12C mutation Strata Oncology will identify patients to be considered for enrollment into Mirati’s P-I/II study. The… Read More »Strata Oncology Collaborates with Mirati Therapeutics to Broaden Enrollment in Clinical Trial of MRTX849 for Patients with Advanced Solid Tumors

Number of cures needed to.eliminate diseases

  • by

have been trying to find a reliable source on number of cures needed to eliminate diseases from this world. Do you have any info that you can share? And why do you think we cannot bring these cures to market? submitted by /u/IamGuruxyz [link] [comments]

Famotidin – contraindicated?

  • by

H2-Blocker Famotidin (Propylenglycol.) and gastrointestinal symptoms My doctor gave me a bunch of new medication today. Including Famotidin. I‘ve just done some research and read it decreases stomach acid production, which is the contrary of what I want. I am actually supplementing with Betaine HCL,… Read More »Famotidin – contraindicated?

Roche Report Mixed Results of Etrolizumab in P-III Studies for Patients with Moderately to Severely Active Ulcerative Colitis

  • by

Shots: In the HIBISCUS I induction study, in patients without prior anti-TNF treatment, etrolizumab met its 1EPs while in HIBISCUS II study in the same kind of people, it did not meet its 1EPs. In the HICKORY study, in patients with prior anti-TNF treatment, therapy… Read More »Roche Report Mixed Results of Etrolizumab in P-III Studies for Patients with Moderately to Severely Active Ulcerative Colitis

Why MedCity News should be your go-to advertising partner

  • by

MedCity News has the most engaged healthcare business audience in the industry. We can collaborate with you to develop customized content or provide a platform for your business to present sponsored thought leadership content highlighting from executives in healthcare and life sciences.

Biogen Signs an Agreement with Denali on LRRK2 Program for Parkinson’s Disease Worth ~$2.125B

  • by

Shots: Denali to receive $560M up front, $465M as equity investment at a price of $34.94/ share, representing 11.2% of Denali’s Pro-forma outstanding stock along with $1.125B as milestones. The two companies will codevelop Denali’s LRRK2 inhibitor for PD and co-commercialize it in the US… Read More »Biogen Signs an Agreement with Denali on LRRK2 Program for Parkinson’s Disease Worth ~$2.125B

UCB’s Cimzia (certolizumab pegol) Receives the EMA’s Approval for a Reduced Maintenance Dose in Patients with Axial Spondyloarthritis Spectrum

  • by

Shots: The P-IIIb C-OPTIMISE study assessing Cimzia (200mg, q2w with a loading dose of 400mg @ 0, 2 & 4wks.) vs PBO during 48wks. open-label induction period in adults with early active axSpA. At 48wks., patients in sustained remission (ASDAS <1.3 @wks. 32/36 & 48)… Read More »UCB’s Cimzia (certolizumab pegol) Receives the EMA’s Approval for a Reduced Maintenance Dose in Patients with Axial Spondyloarthritis Spectrum

Lundbeck Halts P-II Study of Lu AF11167 in Patients with Negative Symptoms of Schizophrenia

  • by

Shots: The company discontinues P-II proof POC study of Lu AF11167 in patients with schizophrenia, who are experiencing persistent negative symptoms (NCT03793712). The P-II study evaluated two doses of Lu AF11167 vs PBO as monothx. in patients with schizophrenia and persistent prominent negative symptoms The… Read More »Lundbeck Halts P-II Study of Lu AF11167 in Patients with Negative Symptoms of Schizophrenia

LEO Pharma Receives the US FDA’s Fast Track Designation for Delgocitinib Cream to Treat Moderate-to-Severe Chronic Hand Eczema

  • by

Shots: The US FDA has granted FT designation to LEO’s delgocitinib cream as the potential treatment for adults with moderate-to-severe CHE. There are currently no treatment options available in the US specifically developed and approved for CHE The FDA’s FT designation facilitates the development and… Read More »LEO Pharma Receives the US FDA’s Fast Track Designation for Delgocitinib Cream to Treat Moderate-to-Severe Chronic Hand Eczema

AstraZeneca Signs a License Agreement with Redx Pharma for RXC006 to Treat Idiopathic Pulmonary Fibrosis

  • by

Shots: Redx to receive $17M in early payment by the time of successful commencement of a P-I study, $360M as development, a regulatory and commercial milestone along with royalties on sales of the RXC006 AstraZeneca to get an exclusive global license to further develop &… Read More »AstraZeneca Signs a License Agreement with Redx Pharma for RXC006 to Treat Idiopathic Pulmonary Fibrosis

The Elusive KOL Pyramid

  • by

The traditional KOL pyramid – you know the one, with the most influential global experts at the top and the front-line national HCPs lower down – is an important construct when identifying and mapping experts. But its simplicity sometimes hides the complexity of real-life. Consider,… Read More »The Elusive KOL Pyramid

RedHill Replaces its Co-Commercialization Agreement with Daiichi Sankyo for Movantik (naloxegol)

  • by

Shots: The new agreement involves, Daiichi to get royalties on sales of Movantik plus payments each year starting from 2021 to 2023. RedHill to take care of all the responsibilities and costs to commercialize Movantik in the US. Additionally, under a subscription agreement Daiichi will… Read More »RedHill Replaces its Co-Commercialization Agreement with Daiichi Sankyo for Movantik (naloxegol)

New speaker session with Kiniksa Pharmaceuticals at Pre-filled Syringes East Coast 2020

  • by

SMi Reports: new speaker session with Paul Roussel, Senior Director, Combination Products, at the Pre-filled Syringes East Coast 2020 conference I am pleased to inform you that Paul Roussel, Senior Director, Combination Products, Kiniksa Pharmaceuticals, has confirmed his position as speaker at the conference. Paul’s… Read More »New speaker session with Kiniksa Pharmaceuticals at Pre-filled Syringes East Coast 2020

Report: GoodRx files for IPO

  • by

GoodRx, a startup that makes tools for comparing the price of prescription drugs, is looking to go public, according to a report by Reuters. The company reportedly submitted paperwork to the Securities and Exchange Commission.

Roche’s Rozlytrek Receives EC’s Conditional Marketing Authorization for NTRK Fusion-Positive Solid Tumors and ROS1-Positive Advanced NSCLC

  • by

Shots: The approval is based on integrated analysis including data from 74 people with LA/ m-NTRK fusion-positive solid tumors (14 tumor types) & 161 people with ROS1+ NSCLC of the pivotal P-II STARTRK-2, P-I STARTRK-1 and P-I ALKA-372-001 trials, and data from the P-I/II STARTRK-NG… Read More »Roche’s Rozlytrek Receives EC’s Conditional Marketing Authorization for NTRK Fusion-Positive Solid Tumors and ROS1-Positive Advanced NSCLC

Takeda’s Pevonedistat Receives the US FDA’s Breakthrough Therapy Designation to Treat Patients with Higher-Risk Myelodysplastic Syndrome

  • by

Shots: The BT designation is based on the final analysis of the Pevonedistat-2001 P-II study assessing pevonedistat + azacitidine vs azacitidine as monothx. in patients with rare leukemias, including HR-MDS The 1EPs of the study include OS, EFS, CR and transfusion independence, and AE profile.… Read More »Takeda’s Pevonedistat Receives the US FDA’s Breakthrough Therapy Designation to Treat Patients with Higher-Risk Myelodysplastic Syndrome

Sangamo Signs a Worldwide License Agreement with Novartis to Develop Genomic Therapies for Three Neurodevelopmental Targets

  • by

Shots: Sangamo to receive $75M upfront within 30 days, $720M milestone payments including up to $420M in development milestones and up to $300M in commercial milestones plus royalties on sales of the product. Additionally, Sangamo to take care of certain research and manufacturing activities funded… Read More »Sangamo Signs a Worldwide License Agreement with Novartis to Develop Genomic Therapies for Three Neurodevelopmental Targets

Eli Lilly Reports Results of Jardiance (empagliflozin) in P-III EMPEROR Trial for Heart Failure Patients with Reduced Ejection Fraction with and without Diabetes

  • by

Shots: The P-III EMPEROR Trial involves assessing of Jardiance (10 mg) vs PBO in two studies EMPEROR-Reduced [NCT03057977, N=3,730] & EMPEROR-Preserved [NCT03057951, N=5,990] in patients with HFrEF & HFpEF respectively The EMPEROR-Reduced study meets its 1EPs in reducing the risk for the composite of cardiovascular… Read More »Eli Lilly Reports Results of Jardiance (empagliflozin) in P-III EMPEROR Trial for Heart Failure Patients with Reduced Ejection Fraction with and without Diabetes

AstraZeneca’s Tagrisso (osimertinib) Receives the US FDA’s BT Designation for the Adjuvant Treatment of Patients with Stage IB-IIIA EGFR-Mutated Lung Cancer

  • by

Shots: The BT designation is based on P-III ADAURA trial which involves assessing Tagrisso (80 mg) vs PBO in 682 patients with Stage IB, II, IIIA EGFRm NSCLC following complete tumor resection and adjuvant chemotherapy as indicated across 20 centers and 200+ countries including the… Read More »AstraZeneca’s Tagrisso (osimertinib) Receives the US FDA’s BT Designation for the Adjuvant Treatment of Patients with Stage IB-IIIA EGFR-Mutated Lung Cancer

Merck’s MK-6482 Receives the US FDA’s Breakthrough Therapy Designation to Treat Patients With Von Hippel-Lindau Disease-Associated Renal Cell Carcinoma

  • by

Shots: The designation is based on P-II study evaluating MK-6482 in patients with VHL-associated RCC with nonmetastatic RCC tumors >3cms in size, unless immediate surgery is required The FDA’s BT designation is granted to expedite the development and review of medicines that are intended to… Read More »Merck’s MK-6482 Receives the US FDA’s Breakthrough Therapy Designation to Treat Patients With Von Hippel-Lindau Disease-Associated Renal Cell Carcinoma

AbbVie Report Results of Rinvoq (upadacitinib) in a P-III AD Up Study for Patients with Atopic Dermatitis

  • by

Shots: The P-III AD Up study involves assessing Rinvoq (15/30mg) + TCS vs PBO + TCS in patients (aged≥12) with the mod. to sev. AD who are candidates for systemic treatment. Patients receiving PBO + TCS were switched to either upadacitinib (15/30mg) + TCS @16wks.… Read More »AbbVie Report Results of Rinvoq (upadacitinib) in a P-III AD Up Study for Patients with Atopic Dermatitis

AstraZeneca Report Results of Farxiga in P-III DAPA-CKD Study for Patients with Chronic Kidney Disease

  • by

Shots: The P-III DAPA-CKD involve assessing of Farxiga ((dapagliflozin, 10mg, qd) + SOC vs PBO in 4,304 patients with CKD Stages 2–4 and elevated urinary albumin excretion, with and without T2D The study met its 1EPs i.e. worsening of renal function or risk of death… Read More »AstraZeneca Report Results of Farxiga in P-III DAPA-CKD Study for Patients with Chronic Kidney Disease

Eli Lilly Amends its 2013 Agreement with Chi-Med to Commercialize Elunate (fruquintinib) in China

  • by

Shots: Chi-Med to receive 70%-80% of Elunate sales in the form of royalties, manufacturing costs and service payments with no upfront regarding this amendment. Lilly will maintain the exclusive commercialization rights and will continue to consolidate the sales of Elunate in China while Chi-Med retains… Read More »Eli Lilly Amends its 2013 Agreement with Chi-Med to Commercialize Elunate (fruquintinib) in China

Gilead and Galapagos’ Jyseleca (filgotinib) Receive the CHMP’s Positive Opinion for Moderate to Severe Rheumatoid Arthritis

  • by

Shots: Then CHMP’s positive opinion is based on P-III FINCH and P-II DARWIN programs that included 4,544 RA patient-years of experience with filgotinib. All three FINCH trials involve a broad range of patients that met their 1EPs  In the trials, the drug achieved ACR20/50/70 and… Read More »Gilead and Galapagos’ Jyseleca (filgotinib) Receive the CHMP’s Positive Opinion for Moderate to Severe Rheumatoid Arthritis

Zydus to Initiate Clinical Study of Desidustat in Patients with Chemotherapy-Induced Anemia (CIA)

  • by

Shots: Zydus has received the US FDA’s approval to initiate clinical trials of Desidustat in CIA. The company has initiated two P-III studies of desidustat The P-III DREAM-ND (NCT04012957) study is being conducted in 588 CKD patients not-on-dialysis while the P-III DREAM-D is being conducted… Read More »Zydus to Initiate Clinical Study of Desidustat in Patients with Chemotherapy-Induced Anemia (CIA)

AstraZeneca’s Breztri Aerosphere Receives the US FDA’s Approval for the Maintenance Treatment of COPD

  • by

Shots: The approval is based on P-III ETHOS study assessing of Breztri Aerosphere (budesonide/glycopyrronium/formoterol fumarate) vs dual therapies [Bevespi Aerosphere (glycopyrronium/formoterol fumarate) and PT009 (budesonide/formoterol fumarate)] with mod. to sev. COPD and a history of exacerbation(s) in the previous year The P-III ETHOS study demonstrated… Read More »AstraZeneca’s Breztri Aerosphere Receives the US FDA’s Approval for the Maintenance Treatment of COPD

BioMarin Reports the Submission of MAA to EMA for Vosoritide to Treat Children with Achondroplasia

  • by

Shots: The MAA is based on P-III study assessing the efficacy and safety of vosoritide, further supported by the long-term safety and efficacy from the ongoing P-II and P-III extension studies and extensive natural history data Following the completion of EMA’s validation, BioMarin expects the… Read More »BioMarin Reports the Submission of MAA to EMA for Vosoritide to Treat Children with Achondroplasia

Ovid Therapeutics and University of Connecticut Collaborate to Accelerate the Development of OV101 (gaboxadol) for Angelman Syndrome

  • by

Shots: Ovid will collaborate with UConn’s Stormy J. Chamberlain and secures exclusive access to identified genetic sequences for shRNA-based therapy. Ovid plans to leverage its translational medicine capabilities and drug development expertise in Angelman syndrome to advance OV101 into clinical Ovid is developing OV101 for… Read More »Ovid Therapeutics and University of Connecticut Collaborate to Accelerate the Development of OV101 (gaboxadol) for Angelman Syndrome

Glenmark Report Results of FabiFlu (favipiravir) in P-III Clinical Study for Patients with Mild to Moderate COVID-19

  • by

Shots: The P-III study assessing the efficacy and safety of Favipiravir + SSC vs SCC in 150 mild to moderate patients, randomized within a 48hour window of testing RT-PCR positive for COVID-19 Results: P-III study the improvement in 1EPs with 28.6% faster viral clearance in… Read More »Glenmark Report Results of FabiFlu (favipiravir) in P-III Clinical Study for Patients with Mild to Moderate COVID-19

AbbVie Reports Results of Rinvoq (upadacitinib) as Monotherapy in a P-III Measure Up 2 Study for Atopic Dermatitis

  • by

Shots: The P-III Measure Up 2 study involves assessing of Rinvoq (15/30mg) vs PBO in adults and adolescents aged 12-18yrs. or older with mod. to sev. AD who are candidates for systemic treatment. Placebo patients were switched to either upadacitinib (15/30mg) @16wks. The study met… Read More »AbbVie Reports Results of Rinvoq (upadacitinib) as Monotherapy in a P-III Measure Up 2 Study for Atopic Dermatitis

Mylan Launches Remdesivir Under the Brand Name Desrem for COVID-19 in India

  • by

Shots: Mylan launches Desrem (remdesivir) addressing the unmet needs amid COVID-19. The drug is approved for the treatment of suspected or laboratory-confirmed incidences of COVID-19 in adults and children hospitalized with severe symptoms Mylan will manufacture Desrem in its state-of-the-art injectable facility in Bangalore, India,… Read More »Mylan Launches Remdesivir Under the Brand Name Desrem for COVID-19 in India

Need help identifying resources on excipients for biopharmaceutical formulations

  • by

Dear all, Guest here. I am researching parenteral (injectable) formulations for bipharmaceuticals. Does anybody know of any databases of approved, marketed products and their formulations? Ideally these databases would contain or at least point to safety data for different formulation excipients. I’ll be grateful for… Read More »Need help identifying resources on excipients for biopharmaceutical formulations

Featured speakers for 2nd annual Wearable Injectors and Connected Devices Conference

  • by

SMi Reports: Featured Speakers listed for SMi Group’s 2nd annual Wearable Injectors and Connected Devices Conference taking place in October. The global wearable devices market size is expected to reach a value of $62.82 billion USD by 2025 with time dependent delivery, improved patient experience… Read More »Featured speakers for 2nd annual Wearable Injectors and Connected Devices Conference

Benefits of Biotech Consulting Services

  • by

An experienced professional pharma consulting service, such as Biotech Research Group, can be hired by companies with variety of their own staff. The consulting firm can fill the void or pick up the extra work if internal staff is over-taxed in responsibilities. Read https://biotechresearchgroup.com/what-is-biotech-consulting-and-how-does-it-benefit-the-pharma-industry/ submitted… Read More »Benefits of Biotech Consulting Services

Developing custom syringes for highly viscous formulations discussed at PFS San Francisco

  • by

SMi Reports: ‘Developing custom syringes for highly viscous formulations’ one of the many topics to be presented at the inaugural Pre-filled Syringes San Francisco Conference on September 14 and 15. SMi Group is holding the inaugural Pre-filled Syringes San Francisco virtual conference, taking place on… Read More »Developing custom syringes for highly viscous formulations discussed at PFS San Francisco

Merck KGaA Takes an Early Option in its Existing Immuno-Oncology Collaboration with F-star

  • by

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 option to license a preclinical program in its existing agreement with F-star Merck KGaA will be… Read More »Merck KGaA Takes an Early Option in its Existing Immuno-Oncology Collaboration with F-star

MSD Collaborates with Novocure to Evaluate Tumor Treating Fields Together with Keytruda (pembrolizumab) in Non-Small Cell Lung Cancer

  • by

Shots: The companies plan to conduct a P-II pilot study of tumor treating fields concomitant with Keytryda for 1L treatment of intrathoracic advanced/ metastatic PD-L1+ NSCLC. The study will enroll ~66 patients with its anticipated initiation in H2’20 The 1EPs od the study will be… Read More »MSD Collaborates with Novocure to Evaluate Tumor Treating Fields Together with Keytruda (pembrolizumab) in Non-Small Cell Lung Cancer

AstraZeneca Report Results of Brilinta (ticagrelor) in P-III THALES Study for Patients with Acute Ischemic Stroke or Transient Ischemic Attack

  • by

Shots: The P-III THALES study involves assessing of Brilinta (180mg as a loading dose followed by 90mg, bid) + aspirin vs aspirin as monothx. in 11,000 patients with non-cardioembolic acute ischaemic stroke or high-risk TIA for 30days Results: 17% reduction in 1EPs of stroke and… Read More »AstraZeneca Report Results of Brilinta (ticagrelor) in P-III THALES Study for Patients with Acute Ischemic Stroke or Transient Ischemic Attack

Treating Pharma Data as an Asset: moving from an application centric to an information-centric organization – presented by Dr. Martin Romacker, Roche

  • by

Pharma knows there is a need for clean, reusable, FAIR data to fuel effective machine learning-driven R&D – but driving effective information and knowledge management is a long process, needing a step change where individuals learn their roles in data stewardship and reduce them to… Read More »Treating Pharma Data as an Asset: moving from an application centric to an information-centric organization – presented by Dr. Martin Romacker, Roche

Gilead’s $2,340 Price for Coronavirus Drug Remdesivir Draws Criticism

The maker of a drug shown to shorten recovery time for severely ill COVID-19 patients says it will charge $2,340 for a typical treatment course for people covered by government health programs in the United States and other developed countries. submitted by /u/arminham1967 [link] [comments]

What are the drivers and opportunities for the cleanroom lighting market?

Factors such as need for controlled environment with extremely low levels of pollutants in manufacturing industries, Stringent regulations in healthcare and food processing industries to prevent contamination of product, and rising demand for sterile manufacturing areas in pharmaceutical industry are fuelling the growth of the… Read More »What are the drivers and opportunities for the cleanroom lighting market?

Want to start a business in the ePharmacy industry?

The growth of the Global ePharmacy market valued approximately USD 42.32 billion in 2019, and it is anticipated to grow USD 107.53 by 2024. Let us understand this ePharmacy industry a little more…. https://medium.com/@kodyTechnolab/how-to-start-online-medicine-delivery-business-ideal-5f5ec7eba354 submitted by /u/KodyTechnolab [link] [comments]

Sourcing investigational COVID-19 drugs

  • by

Are you trying to source investigational COVID-19 drugs? We’ve pulled out all the relevant supply-chain resources at https://www.drugpatentwatch.com/covid-19/ . Let me know what more we can do.. edit: updated url submitted by /u/drugpatentwatch [link] [comments]

The Best discount online pharmacy

  • by

The first online pharmacy (http://rxlegal-online.com) which offers the easiest way of placing order, the fastest shipping to any place on the globe and the cheapest prices on the web. Great deals and free shipping for orders over $200! submitted by /u/Trevor-Mc [link] [comments]

GenScript Signs an Agreement with Selecxine to Develop Therapies for Immuno-Oncology

  • by

Shots: GenScript will be responsible for all pre-clinical pharmacy research and IND filling in Selecxine’s project which is based on cytokine-antibody complexes The company provided development solutions in different hosts tailored to customers and provided the preparation and purification solutions for the final complex,; further… Read More »GenScript Signs an Agreement with Selecxine to Develop Therapies for Immuno-Oncology

Acceleron Signs a License Agreement with Fulcrum for the Identification of Therapies to Treat Pulmonary Diseases

  • by

Shots: Fulcrum to receive $10M upfront, reimbursement for R&D costs, research, development and commercial milestone of up to $295M for first product commercialized and additional payments $143.5M for all subsequent products commercialized plus royalties on sales of product Acceleron to get rights to access Fulcrum’s… Read More »Acceleron Signs a License Agreement with Fulcrum for the Identification of Therapies to Treat Pulmonary Diseases

Eli Lilly Opens its P-III LIBRETTO-531 Clinical Trial for LOXO-292 (selpercatinib) to Treat RET-Mutant Medullary Thyroid Cancer (MTC) Patients

  • by

Shots: The second P-III LIBRETTO-531 involves assessing of selpercatinib vs physician’s choice of cabozantinib or vandetanib in 400 patients in ratio (2:1) with advanced or metastatic RET-mutant MTC who have received no prior systemic therapy for metastatic disease The study will have efficacy endpoints as… Read More »Eli Lilly Opens its P-III LIBRETTO-531 Clinical Trial for LOXO-292 (selpercatinib) to Treat RET-Mutant Medullary Thyroid Cancer (MTC) Patients

Eisai Reports Results of DAYVIGO (lemborexant) in P-III SUNRISE 1 Study in Patients with Insomnia Disorder

  • by

Shots: The P-III SUNRISE 1 (Study 304) study involves assessing of DAYVIGO (lemborexant, 5 or 10 mg) vs an active comparator or PBO in 1,006 patients with insomnia disorder aged 55 years of age or older Results of P-III [email protected] 5/10 mg of DAYVIGO: headache… Read More »Eisai Reports Results of DAYVIGO (lemborexant) in P-III SUNRISE 1 Study in Patients with Insomnia Disorder

Clover Reports Dosing of SCB-808 (biosimilar, etanercept) in P-III Trial in China

  • by

Shots: The P-III study involves assessing of SCB-808 vs Enbrel in patients with AS (axSpA) via SC administration SCB-808 is being developed in the prefilled syringe formulation which is ready for injection and can be self-administered by the patients, thus overwhelming the current Enbrel biosimilar… Read More »Clover Reports Dosing of SCB-808 (biosimilar, etanercept) in P-III Trial in China