Deals:

AstraZeneca is acquiring rare endocrine disease biotech Amolyt Pharma for $800 million upfront and has terms for $250 million in additional milestones.

Merck announced a deal with Pearl Bio, a Khosla Ventures-backed biotech, as part of a package that could be worth as much as $1 billion to create new biologics for cancer.

Amazon announced that it has partnered with Eli Lilly to distribute select medications through the drugmaker’s telehealth offering – including its popular GLP-1 drugs Mounjaro and Zepbound.

Novartis is set to pay up to $835 million for STING antagonist developer IFM Due.

Boehringer Ingelheim announced it will potentially pay up to $732.6 million in a deal with Sosei Heptares to develop potential first-in-class treatments targeting all symptoms of schizophrenia.

Biocon’s unit Biocon Biologics will sell its Indian branded formulations businesses to Eris Lifesciences for $150 million.

Arecor Therapeutics and TRx Biosciences Limited announced a research collaboration to develop an oral GLP-1 receptor agonist product.

Microsoft Research and diagnostics company Cyted announced a collaboration deal to develop novel AI models supporting early detection of esophageal cancer.

FDA:

The agency’s reviewers raised safety concerns over the use of CAR-T therapies from Johnson & Johnson and Bristol Myers Squibb as earlier treatments for blood cancer patients.

The FDA approved Madrigal Pharmaceuticals’ NASH therapy resmetirom.

The agency extended the approval on Regeneron’s Praluent (alirocumab) injection for treating children with a genetic form of high cholesterol.

The FDA’s reviewers said that while Geron Corporation’s myelodysplastic syndromes study met its primary goals, it’s not clear the magnitude and duration of the drug’s benefits outweigh its risks.

The agency declined to approve the monthly injection for treating relapsing forms of debilitating neurological condition multiple sclerosis from Viatris and Mapi Pharma.

Abbott’s recall of HeartMate Touch System has been deemed a Class I recall by the FDA, the most serious designation for a medical device.

Layoffs:

Coherus BioSciences is chopping its head count by 30%.

Kronos Bio announced it will cut 21% of its staff and explore a new dosing schedule for its solid tumor drug.

Spruce Biosciences said it will lay off 20% of its staff.

Takeda Pharmaceuticals announced it will lay off 190 Austrian workers.

Funding rounds: 

Clinical-stage biopharma Cybin announced an oversubscribed private placement of $150 million.

German ADC biotech Tubulis raised $138 million to expand its operations in the U.S.

HiLabs closed a $39 million Series B financing round to support its AI-powered data management products.

Relation Therapeutics raised $35 million in a seed financing round led by DCVC and NVentures, Nvidia’s venture arm.

Asgard Therapeutics raised $32.8 million in a funding round.

Mission Therapeutics raised $32.2 million in a Series D funding round.

AI-powered health tech provider Milu Health secured $4.8 million in seeding funding.

The National Institute on Aging named AgingSense, Cardiost, Gravitrex, Lantern Laboratory, PopCheck Technologies and Voice-It as the winners of its 2023 NIA Start-Up Challenge and Accelerator. 

Industry news:

Oprah Winfrey has set an hour-long ABC primetime special about weight loss drugs following her exit from the board of WeightWatchers.

The Biotechnology Innovation Organization said it will end its association with the Chinese services company WuXi AppTec.

Sanofi said Phase 2b results for amlitelimab support its potential for treating atopic dermatitis.

Additionally, Eli Lilly said a study of its lebrikizumab showed more than two-thirds of people with atopic dermatitis and skin of color experienced skin improvement.

Pfizer reported positive survival findings in a late-stage trial of a treatment of patients with relapsed/refractory diffuse large B-cell lymphoma.

Sandoz announced quarterly net sales totaled $2.5 billion, marking a 10% year-over-year increase at constant currencies.

Peter Thiel-backed Cognition AI debuted Devin, an AI-powered software engineer that can generate, debug and deploy code for websites and videos.

Narcan has been available to buy over the counter for months but a nationwide shortage has restricted access to the opioid overdose reversal drug.

Merck announced plans to conduct clinical trials to evaluate the efficacy and safety of a single-dose regimen of its human papillomavirus vaccine Gardasil 9.

Acadia Pharmaceuticals cut its antipsychotic candidate pimavanserin after it failed a Phase 3 trial for treating schizophrenia.

Regeneron said Eylea HD showed promise in extended dosing for eye diseases.

Autumn Communications announced that it represents Gundry MD, a supplement and gut-health brand.

Healthgrades announced the hospitals named to its 2024 Patient Safety and Outstanding Patient Experience list.

Roche unveiled promising Phase Ib/IIa data for trontinemab, an investigational Alzheimer’s therapy.

Johnson & Johnson announced investigational peptide therapeutic JNJ-2113 maintained high rates of skin clearance through one year in patients with moderate-to-severe plaque psoriasis in a Phase IIb study.

Bristol Myers Squibb dropped another CTLA-4 program from its decade-long research collaboration with CytomX.

Silence Therapeutics’ siRNA drug, Zerlasiran, showed promise in a mid-stage trial as a therapy for patients with high low-density lipoprotein at risk of cardiovascular events.

International pharmaceutical firm Angelini Pharma launched a crowdsourcing campaign exploring ways of target identification in epilepsy.

Drug Channels Institute estimated that U.S. prescription dispensing revenues reached $621 billion in 2023.

Ionis Pharmaceuticals announced positive results from Phase 2 study of ION224, an investigational medicine demonstrating clinical efficacy in the treatment of NASH/MASH.

Catalyst Pharmaceuticals launched Agamree (vamorolone) in the U.S.See last week’s edition of Rx Rundown.