Biogen Inc. and Sage Therapeutics Inc. took Wall Street by surprise with a global tie-up and licensing deal to jointly develop Sage’s late-stage zuranolone (also known as SAGE-217) for major depressive disorder, postpartum depression (PPD) and other psychiatric disorders. SAGE-324 for essential tremor and other neurological disorders is included in the pact.

Rhythm wins first FDA approval for obesity drug Imcivree

Rhythm Pharmaceuticals Inc., a company developing medicines for rare genetic disorders of obesity, has won FDA approval for its first product, Imcivree (setmelanotide), following a priority review. The drug is designed to restore a biological pathway that, when disrupted, can lead to constant hunger. The approval covers the treatment of three types of ultrarare early onset obesity tied to pro-opiomelanocortin, proprotein convertase subtilisin/kexin type 1 and leptin receptor deficiencies, when confirmed by genetic testing.

‘We will understand how humans work’ with Deepmind’s new algorithm

LONDON – The Google artificial intelligence company Deepmind has developed an algorithm that can predict the 3D structure of a protein from its amino acid sequence, making it possible to solve the structures of proteins, such as G protein-coupled receptors (GPCRs), which are a mainstay of drug targeting but whose structure is challenging to determine with current methods.

FDA grants approval for Y-mabs neuroblastoma therapy Danyelza

Just ahead of the U.S. celebration of Thanksgiving, the FDA granted an accelerated approval for Danyelza (naxitamab), a new therapy for certain adults and children with relapsed or refractory high-risk neuroblastoma. The antibody, which Y-mabs Therapeutics Inc. initially sublicensed via a deal with Mabvax Therapeutics Inc. in 2018, is approved for use in combination with granulocyte macrophage colony-stimulating factor. The regulator had assigned the BLA a Nov. 30 PDUFA date.

Moderna seeks EUA for COVID-19 vaccine, reports 100% efficacy against severe disease

Moderna Inc. said Nov. 30 it plans to ask the FDA to bless emergency use of its COVID-19 vaccine, mRNA-1273, after phase III data showed it to be 94.1% effective in preventing symptomatic cases of the disease and 100% effective in preventing severe cases. Efficacy was consistent across age, race and ethnicity and gender demographics, the Cambridge, Mass.-based company said. In addition, the company will apply for a conditional marketing authorization with the EMA, it said. Company shares (NASDAQ:MRNA) rose 16.5% by midday.

As biopharma deals hit records in 2020, massive U.S. government funds flow into industry

If there are three takeaways from this year’s dealmaking efforts, they appear to be record-setting partnerships, lackluster M&As, and massive amounts of research funding via the U.S. government. The COVID-19 pandemic seems to have had little effect on the deal values of biopharma collaborations, licensings and joint ventures. Only 2% of the total projected values involve agreements focused on the deadly virus that is now responsible for taking 1.4 million lives globally. Nevertheless, 2020 will soon slide beyond last year’s record. Mergers and acquisitions, on the other hand, are not as impressive, falling well below two of the last several years. But perhaps the most striking development this year is the massive amount of public-private partnerships between the U.S. federal government and the biopharma industry.

Hookipa CMV vaccine positive in phase II interim peek at three-dose level

Hookipa Pharma Inc. rolled out positive interim phase II data with cytomegalovirus (CMV) vaccine candidate HB-101. The study is measuring safety, immunogenicity and efficacy in individuals receiving a kidney transplant from a living donor. The analysis includes data from 41 participants. Eight were vaccinated with three doses of HB-101 pre-transplant, 19 with two doses, and 14 received placebo. Those vaccinated with three HB-101 doses turned up a 48% reduction in CMV viremia, 42% drop in the use of antiviral therapy, and no CMV disease compared to two in the placebo group. Shares of New York-based Hookipa (NASDAQ:HOOK) were trading midday at $11.75, up 68 cents, settled after trading as high as $13.25.

Canada raises wall to protect its drug supply from U.S.

Canada is putting up barriers to U.S. efforts to take advantage of its northern neighbor’s lower-priced prescription drugs. Canada’s Minister of Health signed an interim order Nov. 27 prohibiting the sale of certain drugs intended for the Canadian market from being distributed outside of Canada, if the sale could cause or exacerbate a drug shortage. The order applies to all drugs subject to mandatory shortage reporting requirements in Canada, including all those eligible for U.S. bulk importation, biologics, controlled substances and drugs being used to treat COVID-19.

Holiday notice

BioWorld's offices were closed in observance of Thanksgiving in the U.S. No issue was published Thursday, Nov. 26, or Friday, Nov. 27.

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