Biopharma News
Aplagon and Cadila Collaborate on Anti-Thrombotic Biologics
The partners will develop a lead anti-platelet, anti-coagulant (APAC) product for treating blood vessel wall injury. Clinical trials are set for 2019 in India.
FDA Approves Amgen’s Avastin Biosimilar
The approval marks the first biosimilar approved in the United States for treating cancers.
EMA Recommends Approval of Herceptin Biosimilar
European Medicines Agency’s Committee for Medicinal Products for Human Use grants a positive opinion for the approval of the biosimilar for treating breast cancer.
Experts Set a 10-Year Roadmap for Optimizing Lyophilization
Focused around Purdue University’s LyoHUB, a new blueprint aims to bring innovation to equipment and processes. One goal? Continuous freeze drying.
FDA Panel Votes Unanimously to Approve GSK Shingles Vaccine
Shingrix represents a new, possibly better alternative to existing treatments.
Alexion Restructures, Moves Headquarters, Closes Facilities, Cuts Jobs
Alexion’s restructuring will reduce its global workforce by 20%, including closing a manufacturing facility in Rhode Island.
J&J Terminates Hep C Collaboration with Achillion
J&J’s Janssen ends a 2015 collaboration with Achillion Pharmaceuticals with a strategic decision to discontinue further development of a hepatitis C therapy in favor of pursuing hepatitis B therapeutics.
Lilly to Cut 3500 Jobs, Aims for $500 Million in Savings
The pharma major anticipates an annualized cost savings of roughly $500 million starting in 2018 based on a significant reduction in its global workforce.
Merck KGaA Considers Sale of Consumer Health Business
As Merck KGaA continues its strategic shift into a science and technology company, it is considering options for its Consumer Health business, including a potential sale.
Merck KGaA Completes $788-Million Divestment of Biosimilars Business
Merck KGaA completes the divestment of its biosimilars business as part of its strategy to focus on developing a pipeline of innovator drugs.
Merck & Co. to Buy German Immuno-Oncology Firm in Nearly $560-Million Deal
With this acquisition, Merck gains a lead anti-tumor drug candidate and a proprietary technology that can potentially induce immediate and long-term anti-tumor immunity.
Roche Recalls Three Lots of Activase on Sterility Issues
Roche’s subsidiary, Genentech, issued the voluntary recall of the anti-stroke drug because of compromised vials containing sterile water that were packaged with the drug.
FDA Clears Pfizer’s ADC for Leukemia
Pfizer’s Mylotarg, an anti-body drug conjugate once voluntarily withdrawn, returns to the market under a new dosing regimen for treating leukemia.
Novartis Appoints New CEO
Novartis has appointed Dr. Vasant Narasimhan as CEO.
BMS and Daiichi Sankyo to Collaborate on Research
Bristol-Myers Squibb (BMS) and Daiichi Sankyo announced a collaboration to evaluate the combination of Opdivo (nivolumab) and antibody drug conjugate (ADC) DS-8201 for treating breast and bladder cancers.
Oncurious to Buy VIB’s Immun-Oncology Portfolio
With this acquisition, Oncurious, a Belgium-based biotechnology company, will gain a pipeline of immune-oncology drug candidates.
Hospira Recalls One Lot of Injectable Vancomycin Hydrochloride
Hospira, a Pfizer company, is voluntarily recalling one lot of vancomycin hydrochloride for injection, USP, 750 mg/vial because of glass within a single vial.
MilliporeSigma Collaborates with Angiex on Cancer Drug
MilliporeSigma announced a collaboration with Angiex, a biotechnology start-up, to support the development of Angiex’s lead oncology antibody drug candidate to clinical use.
FDA Rejects Parkinson’s Disease Drug
FDA issued a Refusal to File letter to Acorda Therapeutics, citing insufficiently complete information in the company’s new drug application for its investigational Parkinson’s disease drug.
FDA Expands Approval for Genentech’s Arthritis Drug
Genentech’s Actemra (tocilizumab), a rheumatoid arthritis drug, has been approved for a new indication, treating CAR T cell-induced cytokine release syndrome (CRS), a side effect of CAR T cell therapy.
Gilead to Buy Kite Pharma for $11.9 Billion
Gilead will gain a robust pipeline of cell therapy products, with one lead candidate, a CAR T therapy, anticipated to gain FDA approval in the fourth quarter.
AstraZeneca and Takeda to Partner for PD Treatment
AstraZeneca and Takeda will partner to develop and commercialize MEDI1341, an alpha-synuclein antibody currently in development as a potential treatment for Parkinson’s disease (PD).
FDA Grants Priority Review to Genentech’s Anti-Cancer Drug
Genentech gets priority review for its application seeking a new indication for its anti-cancer drug, Gazyva (obinutuzumab), in treating follicular lymphoma.
Sanofi Closes Acquisition of Protein Sciences
The acquisition of Protein Sciences, a vaccines biotechnology company, strengthens Sanofi’s influenza vaccines portfolio.
Alembic Sells Indian Formulations Plant
The generic pharmaceuticals firm has sold its Baddi, India formulations manufacturing facility following a recent fire at its joint-venture plant in Algeria.
Genentech Gets Priority Review for Hemophilia A Biologic
FDA grants priority review for emicizumab, an investigational bispecific monoclonal antibody, for treating hemophilia A with factor VIII inhibitors.
Xellia Completes Budapest Facility Expansion
Xellia Pharmaceuticals completed the expansion of its laboratory services building at its Budapest manufacturing site.
Samsung Bioepis Partners with Takeda to Develop Novel Biologics
The first program of this collaboration will focus on the development of a candidate for severe acute pancreatitis.
Shire Announces Director and Senior Management Changes
Shire announced that CFO Jeff Poulton will be leaving the company at the end of the year. Additionally, Joanne Cordeiro has been appointed as CHRO.
