Xencor Inc. and Janssen Biotech Inc., already partners on the development of bispecific antibodies against CD28 for prostate cancer, have reached a second agreement licensing to Janssen exclusive development and commercialization rights to Xencor's phase I bispecific antibody, plamotamab, for the treatment of B-cell malignancies, both as a monotherapy and in combination regimens. Read More
Selecta Biosciences Inc. joined a licensing agreement with Takeda Pharmaceutical Co. Ltd. to develop AAV-driven gene therapies for two lysosomal storage disorders that could bring Watertown, Mass.-based Selecta up to $1.124 billion. The payments depend upon hitting development or commercial milestones. Selecta is also receiving an undisclosed up-front payment and is eligible for tiered royalties on commercial sales. Read More
LONDON – The EMA has changed its stance on booster doses of the Pfizer Inc./Biontech SE COVID-19 vaccine and said they “may now be considered” at least six months after the second dose for people ages 18 and over. Read More
DUBLIN – Redhill Biopharma Inc. is claiming a 62% relative reduction in day 42 mortality from COVID-19 among hospitalized severe patients who received its oral drug, opaganib, as compared with those on placebo. It is also reporting a shorter median time to discharge (10 days vs. 14 days) and a higher proportion of patients on treatment being able to breathe unassisted by day 14 (77% vs. 63.5%). Read More
The 2021 Nobel Prize in Physiology or Medicine was awarded Oct. 4 to David Julius and Ardem Patapoutian “for their discoveries of receptors for temperature and touch.” Read More
PERTH, Australia – Cynata Therapeutics Ltd. has regained rights to its Cymerus mesenchymal stem cell (MSC) product, CYP-001, for graft-vs.-host disease (GVHD) from former licensee Fujifilm Corp., with the two companies negotiating a new partnership under which Fujifilm will manufacture the product. Read More
Developing the next generation of antibiotics is proving to be a major problem, with research reaching an almost standstill due to a lack of funding because of the poor return on R&D investment from the products. Read More
The COVID-19 pandemic has pushed India’s pharmaceutical and medical device industries towards the more widespread use of blockchain as part of a significant digital transformation effort underpinned by growing use of the Internet of Things (IoT), machine learning (ML) and the use of artificial intelligence (AI). Read More
In the latest skirmish over who can get the 340B discounts on prescription drugs that are supposed to help qualifying U.S. providers offer charity care, the Pharmaceutical Research and Manufacturers of America (PhRMA) is challenging a recently passed Arkansas law that seeks to regulate drug manufacturers’ participation in the federal drug pricing program. Read More
At the request of France’s ANSM, the EMA is reviewing drugs containing nomegestrol or chlormadinone to assess the risk of meningioma with their use. Read More
Three generic drug companies have agreed to pay a total of nearly $450 million to resolve U.S. Department of Justice (DoJ) price-fixing allegations. Read More
In addition to the four COVID-19 vaccines it has provisionally approved, Australia’s Therapeutic Goods Administration (TGA) is recommending that two more vaccines – Sinovac Biotech Ltd.’s Coronavac and Astrazeneca plc-Serum Institute of India’s Covishield – be considered “recognized vaccines.” Read More
New hires and promotions in the biopharma industry, including: 9 Meters, Adamis, Adrestia, American Gene Technologies, Annexon, Biogencell, Biomarin, Cytomx, Inflectis, Lianbio, Magenta, Nextcure, Noema, Orasis, Proqr, Valgenesis. Read More
Biopharmas raising money in public or private financings, including: Centessa, Cognition, Helix, Moonlake, Neurobo, Pyxis, Roivant, Trevi, Stealth. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: BMS, Humanigen, Kite, Omeros, Xbrane. Read More
