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Home » Newsletters » BioWorld

BioWorld

March 14, 2022

View Archived Issues
Skin exam

BMS-Nektar phase III melanoma study misses primary endpoints

Four years after Bristol Myers Squibb Co.’s (BMS) $1.85 billion investment in Nektar Therapeutics Inc., the pair’s collaboration has stumbled mightily with a phase III failure. A first analysis their melanoma study, PIVOT IO-001, showed it missed three primary endpoints. The study of interleukin-2-targeting NKTR-214 (bempegaldesleukin) combined with Opdivo (nivolumab) compared to Opdivo monotherapy as a first-line treatment for previously untreated, unresectable or metastatic melanoma did not meet the primary endpoints of progression-free survival and objective response rate. Read More

Signaling Pathway: Ascendis phase III augurs gland future for Transcon PTH

In top-line data from the Pathway phase III trial with Transcon PTH in hypoparathyroidism, Ascendis Pharma A/S provided “what many have been waiting for: a way of therapy to not only boost serum calcium into the normal range, but to make sure that the kidney issues [are] also handled,” said Aimee Shu, vice president of clinical development in endocrinology and co-director of the study, during a conference call with investors. Read More
Closeup of wheelchair

Bridgebio advancing LGMD2i program with positive phase II readout

Discussions with regulators on a proposed phase III trial design are up next for Bridgebio Pharma Inc., which reported positive phase II data for BBP-418 (ribitol) in patients with limb-girdle muscular dystrophy type 2 (LGMD2i), the first of several clinical readouts expected in 2022, as the Palo Alto, Calif-based company looks to regain its footing after disappointing top-line data for its phase III program in transthyretin amyloid cardiomyopathy leveled the stock late last year. Read More
europe-map.png

Europe cutting research links with Russia, Belarus over Ukraine war

Russia and Belarus are being frozen out of international science, with universities and research institutions across Europe suspending joint research projects and calling a halt to the formation of any new collaborations, following the invasion of Ukraine. Initial sanctions announced by European governments called for the severing of direct institution-to-institution links only, with many universities counseling individual researchers to maintain personal relations with Russian peers. Read More
Biosimilars

Future of US biologics competition could rest in PBMs’ hands

2023 may be a pivotal year for biosimilars in the U.S. with a number of approved Humira (adalimumab) biosimilars set for staggered launches under agreements with Abbvie Inc. How successful those launches are, including the launch of Boehringer Ingelheim GmbH’s interchangeable, Cyltezo, and potential other interchangeables, will be determined in large part by three pharmacy benefit managers that together control the prescription drug formularies for nearly 80% of Americans covered by Medicare and private insurance. Read More

Sanofi’s amcenestrant fails in phase II breast cancer trial

Sanofi SA has suffered a setback in its bid to find a successor to Astrazeneca plc’s breast cancer drug Faslodex (fulvestrant) as amcenestrant failed to improve progression-free survival in advanced breast cancer in a mid-stage trial. Read More

SEC identifies firms for tougher audits, including three biopharmas

The U.S. Securities and Exchange Commission (SEC) recently issued a provisional list of five U.S.-listed Chinese companies that reportedly failed to submit necessary accounting reports required under Holding Foreign Companies Accountable Act. The list included three biopharmas: Beigene Ltd., Hutchmed Ltd., and Zai Lab Ltd. Read More

Pfizer authorizes China Meheco Group rights to commercialize Paxlovid in China

Chinese state-owned enterprise China Meheco Group Co. Ltd. has signed a deal with Pfizer Inc. to be its mainland China partner for the commercialization of the COVID-19 pill Paxlovid (nirmatrelvir and ritonavir), which won conditional approval from China’s NMPA earlier this year. Read More
ICYMI illustration

ICYMI: Week in review, March 7-11, 2022

A quick look back at top stories. Read More

Appointments and advancements for March 14, 2022

New hires and promotions in the biopharma industry, including: Achieve, Applied Molecular Transport, Camp4, Crinetics, Curie, Elevation Oncology, Evaxion, Genmab, Illumina, Kamada, Karyopharm, Melinta, Sellas, Veraxa, Verona. Read More

Financings for March 14, 2022

Biopharmas raising money in public or private financings, including: Agile, Biondvax, Impact, Medilink Therapeutics (Suzhou), Nutcracker. Read More

In the clinic for March 14, 2022

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Apnimed, Capricor, Emergent, Prestige. Read More

Other news to note for March 14, 2022

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aikido, Aikomi, Altamira, Arctoris, Arena, Ascletis, ATCC, Avadel, Bright Minds, Catalyst, Calliditas, Chemomab, Concert, Enzolytics, Evariste Technologies, Everest Medicines, Gelmedix, HTL, Ideaya, Index, Kye, Liminal, Neubase, Neximmune, Nuclixbio, Oncoarendi, Pharmabcine, Pfizer, Sandoz, Siwa, Small, Sumitomo Dainippon, Synthetic Biologics, VCN Terran, Virogentics. Read More

Regulatory actions for March 14, 2022

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bayer, Beigene, Hoth, Immunome, Oncternal, Orion, SGC Cell Therapy, Valneva. Read More

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