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Home » Newsletters » BioWorld

BioWorld

July 30, 2021

View Archived Issues
Illustration of digital syringe

Evolutionary modeling warns of COVID-19 vaccine resistance

LONDON – Relaxing of control measures such as mask wearing and social distancing at a time when most of a population has been vaccinated against COVID-19 greatly increases the probability of the emergence of a vaccine-resistant strain, according to a new modeling study. Read More

Peptidream, Alnylam to collaborate on peptide-siRNA conjugates in $2.2B+ deal

Peptidream Inc., fresh off expanding a multibillion-dollar research and license agreement with Takeda Pharmaceutical Co. Ltd. earlier this week, has inked a brand new deal with Alnylam Pharmaceuticals Inc. Valued at up to $2.2 billion, including milestones, the new deal is aimed at the discovery and development of peptide-siRNA conjugates for the delivery of therapies to a wide range of cell types and tissues beyond the liver, the central target of Alnylam's marketed products to date. Read More
Mitochondria illustration

Minovia and Astellas to develop mitochondrial dysfunction therapies

Minovia Therapeutics Ltd. will collaborate with Astellas Pharma Inc. to research, develop and commercialize cell therapy programs for treating diseases brought on by mitochondrial dysfunction. The candidates will come from Astellas’ genetically engineered, induced pluripotent stem cells. Haifa, Israel-based Minovia will receive $20 million in cash up front. Read More
Stock prices with loss/gain arrows

Neuro disease stocks fall in July, but Prothena carries the pack for 2021

Although 14 of the 17 stocks that make up BioWorld’s Neurological Disease Index (NDI) dropped in value over the last month, the index is still ahead by about 9% this year, with a huge surge by Prothena Corp. plc leading the way. Read More
Chinese flag and pills

Chinese regulator releases new guideline to evaluate clinical value of drugs

China’s National Health Commission has just released a new set of regulations to evaluate the clinical value of both approved drugs and those still in trials as part of its efforts to improve the market standards. Read More
Drug research illustration

Japan’s volatile policy direction continues as challenge, but R&D remains strong

Rapid changes, a traditionally conservative approach and a chronic lack of regulatory transparency could undo a lot of the progress that Japan has made in the past few years to speed up approvals and all but eliminate a punishing drug lag that, for decades, held back the development of the country’s biopharma sector. Read More
FDA-yellow-dice.png

FDA sustains ‘any relevant source of evidence’ standard in final intended use rule

The FDA has posted a final rule for its intended use policy for devices, drugs and biologics, which formalizes the elimination of the totality-of-the-evidence approach to determining the manufacturer’s intended use. While the final rule says that mere knowledge of off-label use cannot be the sole determinant of the manufacturer’s intended use, the rule still allows the FDA to infer intended use by “any relevant source of evidence,” a term that may be sufficiently squishy to be functionally equivalent to the controversial totality-of-the-evidence standard. Read More

Appointments and advancements for July 30, 2021

New hires and promotions in the biopharma industry, including: Adaptive Phage, IGM, Immunogenx, Lexicon, Macomics, Merck, Onxeo. Read More

Financings for July 30, 2021

Biopharmas raising money in public or private financings, including: Biomap, Immuneering, Immutep, In8bio, Lifesci, Neukio, Omega, Rani, Tenaya. Read More

In the clinic for July 30, 2021

Clinical updates, including trial initiations, enrollment status and data readouts and publications: AC Immune, Annovis, Atreca, Cassava, Celsion, Daewoong, Endo, Ionis, Mycovia, Newsoara, Palisade, PTC, Regeneron, Roche, Sanofi, Sapience, Satsuma, Scynexis. Read More

Other news to note for July 30, 2021

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Adhera, Hillevax, J&J, Melior, Neopharm, NRG, Protagonist, Rhythm, Siga, Takeda, Urogen, Zandcell. Read More

Regulatory actions for July 30, 2021

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Alzamend, Arrowhead, Basilea, Dicerna, Everest, Fusion, Genentech, Eli Lilly, Nuvox, Oncopeptides, Scancell, Transcenta, Viatris, Vico. Read More

Money raised by biopharma: 2021 vs. 2020 vs. 2019

Total raised in public, private and other financings of biopharma companies, comparing 2021 vs. 2020 vs. 2019. Read More

Biopharma money raised: Jan. 1-July 29, 2021

Year-to-date money raised in public, private and other financings of biopharma companies. Read More
stock prices up

Biggest gainers and losers for the week of July 26-30, 2021

The top 10 biopharma stock gainers and losers for the week. Read More

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