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Regulation

Oct. 1 Quick Takes: Setback at FDA for Mesoblast; plus AMAG, Solid, COVID updates from Gilead, AZ and more 

Oct 2, 2020 | 2:36 AM GMT

Bucking ODAC recommendation, FDA wants another trial from Mesoblast
Mesoblast Ltd. (ASX:MSB; NASDAQ:MESO) said FDA issued a complete response letter to a BLA for remestemcel-L to treat pediatric steroid-refractory acute GvHD. FDA’s Oncologic Drugs Advisory Committee had voted 9 to 1 to back approval of the therapy, but the company said FDA wants at least one more randomized, controlled trial in adults or children to provide more evidence of efficacy. The company will request a Type A meeting with the agency, expected within 30 days, to discuss a potential accelerated approval with a postapproval condition for an additional study.

Gilead assumes responsibility for remdesivir distribution
The U.S. government is no longer controlling domestic allocation of Veklury remdesivir from Gilead Sciences Inc. (NASDAQ:GILD). Recent trends on Veklury orders indicate the supply now outweighs demand, according to HHS Assistant Secretary for Preparedness and Response CMO John Redd. Gilead Chief Commercial Officer Johanna Mercier said the company has “enough supply on hand to treat every existing COVID-19 hospitalization in the U.S. and ample supply for future patients even if the incidence surges. Healthcare providers may continue to order the therapy through AmerisourceBergen Corp. (NYSE:ABC), the sole U.S. distributor. 

CHMP begins rolling review of AZ COVID-19 vaccine

EMA’s CHMP announced Thursday it has begun the first rolling review of an COVID-19 vaccine, AZD1222 from AstraZeneca plc (LSE:AZN; NYSE:AZN) and the University of Oxford, based on preclinical data and immunogenicity data from clinical trials.

FDA lifts hold on Solid DMD study
Solid Biosciences Inc. (NASDAQ:SLDB) gained $1.43 (70%) to $3.46 Thursday after announcing FDA lifted a clinical hold on SGT-001. The hold, placed in July, affected the Phase I/II IGNITE DMD study of the gene therapy to treat Duchenne muscular dystrophy.

Covis to acquire AMAG, marketer of Makena 
Luxembourg-based specialty pharma Covis Group S.a.r.l. will acquire AMAG Pharmaceuticals Inc. (NASDAQ:AMAG) for $13.75 per share in cash, or about $498 million. The share price is a 46% premium to AMAG’s close of $9.40 on Sept. 30.  AMAG markets Feraheme ferumoxyatol to treat iron anemia and Makena hydroxyprogesterone to reduce the risk of preterm birth in women. The drug’s original sponsor, KV Pharmaceutical Co., created a firestorm in 2011 when it priced the drug (see “Only the Pricing is New”).

HHS, Rockefeller Foundation partner on COVID-19 test pilot for schools

HHS and The Rockefeller Foundation are partnering to identify and share effective ways of using rapid, point-of-care antigen tests for asymptomatic COVID-19 screening to support reopening of K-12 schools, with pilot programs launching in Louisville, Ky., Los Angeles, Calif., New Orleans, La., Tulsa, Okla., and the state of Rhode Island. HHS will provide at least 120,000 BinaxNOW tests from Abbott Laboratories (NYSE:ABT), building on its plan to distribute 150 million of the 15-minute tests to communities across the U.S.; Rockefeller Foundation will help the pilot communities develop testing strategies, building on its work with 10 states to make COVID-19 screening more widely available (see “What it Will Take to Get Mass Asymptomatic Screening”).

EUA for IL-6 test to gauge risk of severe COVID-19
FDA granted Beckman Coulter Inc. emergency use authorization for its Access IL-6 immunoassay to detect elevated levels of the cytokine in serum and plasma, which could help clinicians identify COVID-19 patients experiencing a severe inflammatory response that could result in intubation with mechanical ventilation. Clinical data on the effects of IL-6 inhibitors in treating patients with severe COVID-19 has been mixed; the biggest benefit so far has been reducing the need for mechanical ventilation (see “Genentech Finds Right Endpoint to Show IL-6 Benefit in COVID-19”).

Breakthrough designation for Genetron early HCC detection test
Genetron Holdings Ltd. (NASDAQ:GTH) received breakthrough device designation from FDA for its HCCscreen blood-based next-generation sequencing (NGS) test to detect hepatocellular carcinoma (HCC) in high-risk individuals with chronic HBV infection and/or liver cirrhosis. The company has launched HCCscreen as a laboratory-developed test in China, and is building a CLIA laboratory in Maryland to support development of the test for the U.S. market.

ILiAD whooping cough vaccine induces mucosal immunity
ILiAD Biotechnologies LLC has presented data showing BPZE1 met the co-primary endpoints of safety and immunogenicity in a Phase IIb study. On Tuesday at the virtual World Vaccine Congress, the company also demonstrated the live attenuated pertussis vaccine prevented revaccination/challenge in 90% of subjects three months after a single immunization.

Oncorus raises $87M in IPO
Oncorus Inc. (NASDAQ:ONCR) raised $87 million in an IPO that gave the oncolytic virus company a valuation of $327.7 million.  It sold 5.8 million shares at $15, the midpoint of its proposed $14-16 range.

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