Global Pharma Briefs: News from the US

A roundup of news from the US (AbbVie, Colorcon Ventures, BioMarin Pharmaceutical, and Bayshore Pharmaceuticals).

AbbVie, Harvard Form $30-M Research Pact for Emergent Viral Diseases
AbbVie and Harvard University have entered into a $30-million collaborative research alliance to launch a multi-pronged effort at Harvard Medical School (HMS) to study and develop novel therapies against emergent viral infections, with a focus on those caused by coronaviruses and by viruses that lead to hemorrhagic fever.

The collaboration aims to integrate fundamental biology into preclinical and clinical development of new therapies for viral diseases that address a variety of therapeutic modalities. HMS has led several large-scale, coordinated research efforts launched at the beginning of the COVID-19 pandemic.

AbbVie will provide $30 million over three years and additional in-kind support using AbbVie’s scientists, expertise, and facilities to advance collaborative research and early-stage development efforts across five program areas that address a variety of therapeutic modalities: (1) immunity and immunopathology; (2) host targeting for antiviral therapies; (3) antibody therapeutics; (4) small molecules; and (5) translational development.

Source: AbbVie

Colorcon Ventures Invests in AI Company Atomwise
Colorcon Ventures, a $50 million corporate venture fund of Colorcon, a manufacturer of film-coating systems and excipients, has invested in Atomwise, a provider of artificial intelligence (AI) services for drug discovery and structure-based drug design. The company’s technology, called AtomNet, removes the barriers of physical screening in small- molecule drug discovery and is able to screens libraries of over 16 billion molecules against novel biological targets in less than two days, according to information from Colorcon.

Source: Colorcon

BioMarin Receives Complete Response Letter from FDA
BioMarin Pharmaceutical, a San Rafael, California-based pharmaceutical company has received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) for the company’s biologics license application (BLA) for valoctocogene roxaparvovec, a gene therapy for severe hemophilia A. The FDA issues a CRL to indicate that the review cycle for an application is complete and that the application is not ready for approval in its present form.

The company had previously agreed with the agency on the extent of data necessary to support the BLA, and the FDA has introduced a new recommendation for two years of data from the company’s ongoing Phase III study to provide substantial evidence of a durable effect using annualized bleeding rate as the primary endpoint. The agency first informed the company of this recommendation in the CRL, and the company says that the agency had not previously raised this recommendation at any time during development or review.

The agency is recommending that the company complete the Phase III study and submit two-year follow-up safety and efficacy data on all study participants. The Phase III study was fully enrolled in November 2019, and the last patient will complete two years of follow-up in November 2021.

BioMarin says it plans to meet with the agency in the coming weeks (as reported on August 18, 2020) to align on the next steps to obtain approval. BioMarin says that ongoing valoctocogene roxaparvovec clinical trials will continue while BioMarin is exploring the next steps to obtain approval. The European Medicines Agency’s review of the company’s marketing authorization application for valoctocogene roxaparvovec is ongoing.

Source: BioMarin Pharmaceuticals

Bayshore Recalls Two Lots Diabetes Drug Metformin for NDMA Impurity
Bayshore Pharmaceuticals, a Short Hills, New Jersey-based pharmaceutical company, is voluntarily recalling in the US select lots of metformin extended-release formulations, a drug to treat Type 2 diabetes, due to evaluated levels of a nitrosamine impurity, N-nitrosodimethylamine (NDMA), a potential carcinogen.

Bayshore is voluntarily recalling one lot of metformin hydrochloride extended-release tablets USP, 500 mg, 1,000-count bottles and one lot of metformin hydrochloride extended-release tablets USP, 750 mg, 100-count bottles within expiry to the consumer level due to the detection of NDMA levels above the acceptable daily intake limit. The US Food and Drug Administration’s (FDA) acceptable intake limit for NDMA in drug formulations is 96 nanograms per day. This product was manufactured by Beximco Pharmaceuticals, a Dhaka, Bangladesh-headquartered pharmaceutical company, in June 2019, for US distribution by Bayshore.

The affected lots were distributed nationwide in the US by Bayshore directly to wholesalers and distributors.

Source: US Food and Drug Administration

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