FDA Policy/General

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Momenta Pharmaceuticals and Mylan have entered into a collaboration agreement to develop, manufacture and commercialize six of Momenta’s current biosimilar candidates, including a version of Bristol-Myers Squibb’s Orencia (abatacept), indicated for treating rheumatoid arthritis. Under the agreement, Mylan will make an upfront $45 million cash payment to Momenta, and it is committed to pay up to $200 million in contingent milestone payments.

Allergan has acquired a clinical stage biopharmaceutical company, Anterios, Inc., which is developing a next-generation delivery system and botulinum toxin-based prescription products. Allergan paid $90 million upfront and will make potential development and commercialization milestone payments related to NDST, Anterios’ proprietary platform delivery technology that enables local, targeted delivery of neurotoxins through the skin without the need for injections. Allergen says it has also acquired global rights to ANT-1207, an investigational topical formulation botulinum toxin type A in development for the potential treatment of hyperhidrosis (excessive sweating), acne, and crow’s feet lines.

EpiVax, Inc. and Aceno Biotherapeutics will participate in a new venture in which Aceno will use advanced computational tools to actively develop a portfolio of “biobetter” therapeutics that will be “immune-engineered” by EpiVax. Aceno says biosuperiors, unlike biosimilars, are related to existing marketed biologics by target or action and Immune Engineering the protein sequence will reduce undesirable effects, such as an immune-mediated response that generates anti-drug-antibodies.

Janssen Sciences Ireland formalized its collaboration with ViiV Healthcare on Phase 3 development and commercialization of a two drug regimen of long acting, all-injectable formulations of rilpivirine (a non-nucleoside reverse transcriptase inhibitor by Janssen) and cabotegravir (ViiV Healthcare).The companies says ViiV Healthcare will lead in evaluating the efficacy, safety and tolerability of the regimen, with support from Janssen.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome