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Federal securities regulators are asking questions about an Ocular Therapeutix eye pain product that was rejected by the FDA in July.

Ocular (NASDAQ: OCUL) received a subpoena from the Securities and Exchange Commission dated Dec. 15, the Bedford, MA, company said Friday after the markets closed. The subpoena seeks documents and information regarding the company’s lead product candidate, Dextenza. In a news release, Ocular characterized the SEC communication as a “non-public, fact-finding inquiry.”

The company gave no details about what the SEC was asking, though it did say that the regulator’s inquiry covers communications with the FDA, investors, and… Read more »

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Federal securities regulators are asking questions about an Ocular Therapeutics eye pain product that was rejected by the FDA in July.

Ocular (NASDAQ: OCUL) received a subpoena from the Securities and Exchange Commission dated Dec. 15, the Bedford, MA, company said Friday after the markets closed. The subpoena seeks documents and information regarding the company’s lead product candidate, Dextenza. In a news release, Ocular characterized the SEC communication as a “non-public, fact-finding inquiry.”

The company gave no details about what the SEC was asking, though it did say that the regulator’s inquiry covers communications with the FDA, investors, and unspecified… Read more »

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Scott Kelley has been appointed chief medical officer of Flexion Therapeutics (NASDAQ: FLXN). Kelley was previously vice president of medical affairs for the Burlington, MA, drug developer. He succeeds Yamo Deniz, who has left the company. Before joining Flexion in 2016, Kelley was vice president of global medical affairs at Sanofi (NYSE: SNY). Flexion develops treatments for musculoskeletal conditions, such as osteoarthritis.

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The lead drug in a wide-ranging Alzheimer’s disease collaboration between Biogen and Eisai has flunked its first test, falling short of its main goal in a mid-stage clinical trial.

Biogen (NASDAQ: BIIB) and Eisai said Thursday an independent interim analysis at 12 months found that the drug BAN2401 failed to show enough of a change on assessment scores used to evaluate patients in the early stages of Alzheimer’s disease. But the companies will continue the study to gather more data.

BAN2401 is a monoclonal antibody that binds to amyloid beta plaque to break up the accumulation of this protein on… Read more »

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Nearly 40 million Americans say they have trouble hearing for one reason or another. There are no drug treatments, just hearing aids and cochlear implants, but biotech companies such as Frequency Therapeutics and Decibel Therapeutics believe they now have the means to make noise in this largely untapped market.

The race to drug the ears, so to speak, might soon include gene editing tools. In a paper published today in the journal Nature, scientific founders of Decibel and Editas Medicine (NASDAQ: EDIT), a leading CRISPR-Cas9 drug firm, and other authors show how they used the CRISPR-Cas9 gene editing system… Read more »

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After a five-month search, Zimmer Biomet announced that medical device industry veteran Bryan Hanson is now the company’s top executive.

Warsaw, IN-based Zimmer Biomet (NYSE: ZBH) said Hanson’s appointment was effective Tuesday. He replaces interim CEO Daniel Florin, who will resume his duties as senior vice president and CFO.

Zimmer Biomet sells musculoskeletal medical devices used in a wide range of orthopedic, sports medicine, and surgical applications. Hanson brings to the company a long resume in medical devices. Most recently, he worked at Medtronic (NYSE: MDT), where he was executive vice president of the company’s executive committee, and vice… Read more »

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