LONDON – Family-owned Angelini Pharma is to buy Swiss startup Arvelle Therapeutics GmbH for $960 million, acquiring full European rights to the epilepsy drug cenobamate. The first tranche, of $610 million, will be paid following the EMA’s recommendation to approve cenobamate, which is expected at either the January or February meeting of the Committee for Medicinal Products for Human Use. Read More
NEW DELHI – The Drugs Controller General of India (DCGI) granted its first emergency conditional approvals Jan. 3 for a pair of COVID-19 vaccines, including Covishield, developed abroad by Astrazeneca plc and Oxford University and manufactured by the Pune-based Serum Institute of India (SII). The DCGI also approved Covaxin, which was developed locally by Hyderabad-based Bharat Biotech International Ltd. in collaboration with the Indian Council of Medical Research, and is still in phase III trials. Read More
While everyone will be glad to see 2020 in their rearview mirror, the biopharmaceutical sector can count its blessings, as it emerges from a period where it has surprisingly received record public and private financings and enjoyed strong investor support. This is in sharp contrast to most of the global economy, which has been decimated by the ongoing pandemic. Read More
A metastatic renal cell carcinoma (RCC) trial once expected to pave a path to registration for the Calithera Biosciences Inc. candidate telaglenastat failed to show a benefit from the drug in a new analysis of the pivotal phase II study, Cantata. While company executives voiced confidence in the drug's prospects in another indication, non-small-cell lung cancer (NSCLC), analyst and investor faith appeared less sturdy, as company shares (NASDAQ:CALA) fell 44.6% to $2.72 on Jan. 4. Read More
Following a record-shattering year, terms were set for the first two biotech IPOs of 2021 in deals that could generate up to $300 million. Cullinan Oncology LLC, of Cambridge, Mass., set terms Jan. 4 for raising about $150 million by pricing 8.3 million shares in the $17 to $19 range. Gracell Biotechnology Ltd., of Shanghai, also set the terms for its U.S. IPO Jan. 4. The CAR T-cell developer looks to raise $150 million by offering 8.8 million American depositary shares in a range of $16 to $18 each. Read More
HONG KONG – Hutchison China Meditech Ltd. (Chi-Med) earned approval from China’s National Medical Products Administration (NMPA) for Sulanda (surufatinib) for the treatment of non-pancreatic neuroendocrine tumors (NETs), marking what CEO Christian Hogg called a “major milestone” as the first drug to be discovered and developed by Chi-Med without the support of a development partner. Read More
Sutro Biopharma Inc.’s stock-perking news in early December with STRO-002, a folate receptor alpha-targeting antibody-drug conjugate (ADC) to treat ovarian cancer, reminded investors of potential in the class, which has been more than realized in recent years and could yield more upside in the near term. As of the Oct. 30 cutoff date, STRO-002 tallied one complete response and nine partial responses in the challenging indication, which works out to an overall response rate of 32% (10 out of 31) in evaluable patients. Read More
The U.S. Department of Health and Human Services (HHS) released an advisory opinion last week saying that drug manufacturers are obligated to provide 340B pricing for outpatient drugs dispensed by contract pharmacies on behalf of hospitals and clinics that qualify for the discounts. But the opinion said nothing about enforcement action or assessing civil penalties against manufacturers who refuse to do so. Read More
And just like that, it’s over. Bristol Myers Squibb Co. on Jan. 1 confirmed what many suspected, that FDA approval for lisocabtagene maraleucel (liso-cel) did not happen by the Dec. 31 deadline, thereby automatically terminating the contingent value rights (CVR) agreement issued as part of its acquisition of Celgene Inc. Read More
New hires and promotions in the biopharma industry, including: Adrenomed, Cassava, Celldex, Enzon, G1, Intravacc, Myovant, Neximmune, Pliant, Obseva. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aptinyx, Biohaven, Calithera, Dicerna, F-star, Harpoon, Insmed, Kaleido, Kendrion, Landos, Mei, Pandion, Wu, Tiziana. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Advaccine, Astrazeneca, Azurrx, Biocure, Bonus, Califia, Cheplapharm, Entheon, Epivax, First Wave, Generation, Heading, Hoth, Inovio, Lantern, Moderna, Novus, Oncorus, Symbasis, Taysha, Wize. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ambrx, Antengene, Arcturus, Atara, Ayala, Bioniz, BMS, Forge, Inozyme, Matinas, Opko, Passage, Pfizer, Provention. Read More
