AI drug discovery specialist Insilico Medicine Inc. has landed a multiyear research deal with Sanofi SA to develop candidates for up to six new targets in undisclosed indications. The collaboration included $21.5 million up front for Insilico, and as much as $1.2 billion in additional payments from Sanofi if key research, development and sales milestones are met.

FDA briefing docs seem promising for Veru’s COVID-19 drug

The U.S. FDA’s Pulmonary-Allergy Drugs Advisory Committee (PADAC) is taking up the matter Nov. 9 of Veru Pharmaceuticals Inc.’s emergency use authorization request for microtubule disrupter VERU-111 (sabizabulin) to treat hospitalized adults with moderate to severe COVID-19 who are at high risk for acute respiratory distress syndrome (ARDS). Shares of the company (NASDAQ:VERU) shot from $10:35 to $15.03 between Nov. 4 and Nov. 7, as Wall Street digested upbeat briefing documents. The lone voting question for PADAC panelists is: “Do the known and potential benefits of VERU-111 when used for the treatment of adult patients hospitalized with COVID-19 at high risk of ARDS outweigh the known and potential risks of VERU-111?” Miami-based Veru’s stock was trading midday at $14.43, down 10 cents.

Sensorium raises $30M in series A round to probe plants, fungi for psychoactive natural products

Sensorium Therapeutics Inc. closed a $30 million series A round to fund the discovery and development of new psychiatric drugs, inspired by human ethnobotanical practices that date back hundreds or even thousands of years. The Boston-based firm is bringing a wealth of clinical, neurological and chemical expertise to bear on what is a longstanding problem in neuropsychiatric drug discovery – the deep complexity of disease biology coupled with a general lack of reliable animal models to aid translational research.

Luye’s antidepressant approved for marketing in China

Luye Pharma Group has received marketing approval from China’s NMPA for the triple monoamine reuptake inhibitor Ruoxinlin (toludesvenlafaxine hydrochloride) to treat patients with major depressive disorder (MDD). “MDD has become one of the most prevalent mental disorders in China, causing a heavy burden on patients, their families, and the entire society,” said Yang Rongbing, president of Luye Pharma.

Innovent bolsters case for hypercholesterolemia MAb with phase III results

Innovent Biologics Inc. said that, compared to a placebo, both doses of its anti-PCSK9 monoclonal antibody, tafolecimab, tested in a phase III trial “yielded significant and durable reductions” in low-density lipoprotein cholesterol levels and showed a favorable safety profile in Chinese patients with non-familial hypercholesterolemia. If approved following an ongoing review at the NMPA, the candidate could become the first locally developed PCSK9 MAb approved in China.

Europe continues its decline in Rx innovation

Europe is losing its innovative edge in biopharma, especially when it comes to advanced therapy medicinal products (ATMPs), including tissue, gene and cell therapies used to prevent, treat and cure rare conditions. While European institutions continue to outpace their counterparts in China and the U.S. with academic research on ATMPs, Europe has fallen behind in turning that research into therapies, according to a report released this week by the European Federation of Pharmaceutical Industries and Associations. Between 2017 and 2019, European institutions authored 48,000 more publications on ATMPs than the U.S. and 20,000 more than China. Yet ATMP clinical trial activity is twice as high in the U.S. and nearly three times as high in China than in Europe.

Ausbiotech 2022: Japan offers model for building sustainable regenerative sector

“We look at Japan with some envy with what they’ve been able to achieve and their approach to regenerative medicine, which has been supported significantly by their federal government,” said Silvio Tiziano, CEO of the Center for the Commercialization of Regenerative Medicine Australia, during the recent Ausbiotech conference in Perth. So far, 17 regenerative therapies have been approved in Japan, and Japanese regulators continue to optimize regulations related to regenerative medicine.

Pace slows for biopharma deals; fewest M&As since 2013

Despite coming out strong earlier this year, biopharma deals have slowed significantly, with values now falling behind 2021 by 7.6%. In August, deals were ahead of all recent years, showing a 7% increase over last year. Through early November, the industry has completed 1,296 deals, including licensings, joint ventures and collaborations, valued at $154.6 billion. This is down from the 1,710 deals worth $167.4 billion by this point last year. Completed mergers and acquisitions in 2022 have reached 81 worth $70.6 billion. It is the fewest number of M&As for a single year since 2013.

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