Myovant Sciences Ltd. has turned down an unsolicited buyout bid from Sumitovant Biopharma Ltd., a wholly owned subsidiary of Sumitomo Pharma Co. Ltd., that reflects an enterprise value of $2.5 billion and an equity value of $2.4 billion, saying the offer “significantly undervalues” the company. The proposed price, $22.75 per share in cash for each Myovant share (NASDAQ:MYOV) not already owned by Sumitomo, represents a 26.7% premium to the Sept. 30 closing amount of $17.96. Myovant was trading midday at $24.76, up $6.76, or 37.6%.

From ancient DNA, a Nobel Prize, and perhaps modern drug targets

The Nobel Prize in Physiology or Medicine 2022 was awarded to Svante Pääbo Oct. 3 "for his discoveries concerning the genomes of extinct hominins and human evolution." Pääbo, who is currently the director of the Max Planck Institute for Evolutionary Anthropology in Leipzig, Germany, and his colleagues overcame extreme technical challenges to sequence the DNA of ancient hominids – because after tens of thousands of years, there is no such thing as aging well for DNA.

Final FDA user fee bill omits LDT regulation, accelerated drug approval program reforms

The U.S. Congress has finally managed to pass legislation that reauthorizes a number of FDA user fee programs, but the final vote came on the last day of the federal fiscal year and addressed a stripped-down version of previous user fee bills. While several key considerations survived the shift to a lean bill, the FDA will have to wait for another day to be authorized to regulate lab-developed tests and to revise the accelerated approval program for pharmaceuticals, measures that may be revisited before the end of the current calendar year.

Incyte swoops for vitiligo specialist Villaris in potential $1.43B deal

Incyte Inc. has agreed to acquire Villaris Therapeutics Inc., the developer of a monoclonal antibody to treat vitiligo that aims to treat a larger proportion of the skin than available topical cream, for $70 million up front, plus up to $310 million in potential development and regulatory milestone payments. The deal includes up to $1.05 billion in commercial milestones on net sales of auremolimab, a preclinical MAb that works against IL-15Rβ and is expected to reach the clinic in 2023.

FDA greenlights Taiho’s FGFR inhibitor Lytgobi for intrahepatic cholangiocardinoma

The U.S. FDA has approved Taiho Oncology Inc.’s Lytgobi (futibatinib) for adults with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements. The approval arrived on its Sept. 30 PDUFA date.

Biopharmas expect rising energy costs to dent profits

Companies across biotech and pharma are scrambling to find ways of reducing their energy consumption and overall dependence on fossil fuels, following the sudden and stark increase in prices sparked by Russia’s invasion of Ukraine. More than 80% of businesses have been forced to make changes to counter rising energy bills, according to a worldwide survey of 126 senior executives in the sector. Overall, 36% of pharma and biotech respondents described these changes as radical.

Industry pushes back as WTO considers broader COVID-19 waiver

Now that a patent waiver is in place for COVID-19 vaccines, World Trade Organization (WTO) members are discussing extending it to therapies, diagnostics and devices used in confirming and treating COVID-19 infections. Industry is pushing back with all the reasons an extension is not a good idea. For starters, there is no shortage problem that requires a broader waiver, according to a new analysis by the European Federation of Pharmaceutical Industries and Associations. The analysis noted that extending the waiver would expand its scope from 4,303 patents to 135,627 patents globally, “across pharmaceuticals, chemicals, machinery, rubber, glass and other industries, beyond healthcare.”

US senators to HHS: Enforce 340B Rx discounts

The U.S. Department of Health and Human Services (HHS) needs to do more and act faster to crack down on drug manufacturers that restrict 340B prescription drug discounts to contract pharmacies, two senators said in a letter to HHS Secretary Xavier Becerra. “The restrictions imposed by drug companies on 340B discounts are causing alarming financial losses for safety-net hospitals, health centers and other 340B providers as more companies impose such limits and increasingly target discounts on costly specialty drugs,” Sens. Joe Manchin (D-W.Va.) and Mike Braun (R-Ind.) said in the letter. “HHS [Office of Inspector General] needs to fully enforce the law against all drug manufacturers who unlawfully overcharge safety-net health care providers.”

Also in the news

Adverum, Airway, Alexion, Alloy, Alnylam, Altamira, Amplifybio, Apellis, Astrazeneca, Atsena, Aura, Bavarian Nordic, Belite, Biocardia, Biogen, Chromadex, Citius, Clene, Clovis, Denali, Edesa, Enanta, Genmab, Idorsia, Immuneering, Immupharma, Inflammx, Janssen, Lepu, Lexicon, Ligand, Omeros, Oxford, Pact, Pharmaust, Recce, Redx, Regeneron, Sanofi, Seelos, Therapeuticsmd, Timber, Toragen, Valbiotis, Venatorx, Vivera, Y-Mabs