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There’s no boring day in biopharma, and this was especially true this week with multiple exclusives and scoops from the Endpoints team. See if you missed anything!
Vertex’s $4.9B bet
Hours after the rumors surfaced on Wednesday, Vertex announced it would pay $4.9 billion for Alpine Immune Sciences and its experimental drug povetacicept to treat IgA nephropathy, a kidney disease that’s attracted increasing interest ranging from big drugmakers to VCs. It marks Reshma Kewalramani’s first major deal as CEO, and the latest expansion in Vertex’s scientific focus.
Layoffs at Novartis, Genentech
Several big drugmakers are trimming their headcount ahead of earnings season. Novartis plans to shrink its global development team by up to 680 roles, while Roche’s Genentech unit will cut 3% of staffers as it shifts resources.
Sanofi drops cancer work to avoid repeating bets
In a move away from oncology, Sanofi is parting ways with two companies it acquired in recent years. It will close down Kiadis, the Dutch off-the-shelf natural killer cell therapy company it bought three and a half years ago for $357 million, and is set to divest a site and assets under Amunix Pharmaceuticals, an immuno-oncology biotech it acquired for $1 billion a little after that. The move will also lead to layoffs of about 100 workers in California.
Star founders unveil new startups
Some of the biggest names in the gene editing and neuroscience fields launched new startups this week. Nvelop Therapeutics emerged with $100 million in seed funding to advance delivery research from the gene editing pioneers David Liu and Keith Joung, while Steve Paul is reuniting with PureTech founder Daphne Zohar for another neuro biotech, just months after they sold their last one.
#AACR24 dispatches
After spending time with scientists and clinicians in San Diego, our science reporters are back with two observations from the AACR confab: Ryan Cross writes about how, after decades of false starts, early cancer vaccine data are breathing new life into the field, even as many questions remain. Lei Lei Wu brings us a look at the boom of new work in KRAS after the first approvals against the target once considered undruggable. One of the companies touting next-gen KRAS data was China’s D3 Bio, which also reloaded with a $40 million investment from Medicxi.
SPOTLIGHT
Big comeback? The Q1 report on biotech is in, and there’s been some sputtering
The latest data from DealForma’s Chris Dokomajilar backs up some of the things we were already pretty sure about — while raising new questions about just how deep and lasting this biotech recovery can be, John Carroll writes in his Q1 review.
ADC dealmaking is red hot. Is it sustainable?
DEALS
- Merck will pay up to $208 million to buy Abceutics, a startup that’s working on companion compounds to potentially make antibody-drug conjugates safer by neutralizing stray payload molecules and limiting side effects on healthy cells.
- Novartis wanted just one drug from MorphoSys before upping bid for whole company, document reveals
- Novartis lines up protein degrader deal with Pfizer-allied Arvinas
- Adaptimmune loses $3B biobucks pact with Genentech
- Ginkgo, Novo Nordisk forge ‘flexible’ research pact, from discovery to manufacturing
- Illumina receives EU clearance for planned Grail divestment
- Boehringer Ingelheim taps Sino Biopharm as Chinese partner for its emerging cancer pipeline
- I-Mab CEO details considerations behind China split, hints at potential in-licensing
#AACR24
- FDA officials raise concerns with immunotherapy overuse for early-stage cancer patients: #AACR24
- AstraZeneca eyes a safer PARP inhibitor, with nearly 50% response in advanced breast cancer patients: #AACR24
- AstraZeneca’s ‘radiosensitizer’ may enhance efficacy of radiation for deadly brain cancer: #AACR24
PEOPLE
- Siduma Therapeutics, a Yale spinout from Arvinas scientific founder Craig Crews, has closed, a decision attributed to a challenging funding environment for early-stage science.
- Exclusive: Top lobbyist at BIO leaves as trade group grapples with US-China tensions
- Illumina CFO to depart; Jude Samulski ends his run as AskBio’s CSO
FINANCING
- Another ADC biotech reels in big bucks as Mark Alles’ TORL nabs $158M
- Obesity drugmaker lands first biopharma uplisting onto Nasdaq since last summer
R&D
- Bristol Myers touts long-term efficacy of recently acquired Karuna drug
- Fresh off ALS drug withdrawal, Amylyx touts interim rare disease data for the same therapy
- Lipocine’s weight loss drug shows early signs of keeping muscle mass in Ph2
- With Ph3 data, Pfizer wants to have the ‘first and only’ RSV vaccine to cover adults as young as 18 years old
- Novartis pauses enrollment for Kisqali breast cancer trials to align with nitrosamine guidelines
- Enlivex’s shares cut in half after ‘biases’ cloud Ph2 cell therapy data in sepsis
- BrainStorm outlines plans for what may be final attempt to bring ALS drug to market
#ACC24
- Alnylam’s RNAi therapy passes second Phase 2 hypertension test, with third underway: #ACC24
- Novo further boosts evidence for semaglutide’s heart benefits beyond weight loss: #ACC24
- Ionis presents pivotal rare disease data, builds toward first solo launch: #ACC24
- Arrowhead reports full Phase 2b data for lipid drug, but Ionis is a step ahead: #ACC24
FDA+
- The FDA indicated that it’s open to a new endpoint that could accelerate the development of new treatments for multiple myeloma, writing in briefing documents ahead of an adcomm that minimal residual disease may be an appropriate intermediate clinical endpoint. Its expert advisors agreed, voting unanimously to support its use in accelerated approvals.
- FDA commissioner calls on House committee to help combat drug shortages
- Nearly half of cancer drugs granted accelerated approval didn’t end up showing clinical benefit — study
- Novartis, Sanofi and PhRMA push FDA on how to better handle complex trial designs
- EMA probe finds no causal link between semaglutide and suicidal thoughts, self-harm
- FDA issues second CRL to Supernus for Parkinson’s drug-device combo
- AstraZeneca’s Fasenra expands approval in children with severe asthma
- Stealth Bio gets FDA adcomm for previously rejected ultra-rare disease drug
CELL/GENE TX
- CMS to increase reimbursement for new sickle cell gene therapies
- FDA approves J&J and Legend’s Carvykti for second-line multiple myeloma
PHARMA
- Over a year after biosimilars started competing with AbbVie’s Humira — and with nine biosimilars on the market — brand-name Humira still holds 96% of the Humira market, according to a new report. And the slow uptake is leading one drugmaker to cut back its sales staff.
- SEC notches win in biopharma ‘shadow’ insider trading case
- European Parliament adopts pharma legislative revamp by wide margin
- Virginia governor vetoes bill to create advisory board to reduce drug prices
LAW
- Eli Lilly suffered another loss in its legal campaign against compounded versions of its popular diabetes and weight loss drug tirzepatide, as a federal judge in Florida tossed its lawsuit.
- US sues Regeneron over ‘hundreds of millions’ in allegedly inflated Medicare reimbursements for Eylea
- Endo sues FDA over its handling of generic Adrenalin approvals
MARKETING
- From monsters to dinosaurs and superheroes, pharma is bringing animated characters back into the ad mix. Beth Bulik digs into why.
- Lady Gaga returns in a new Nurtec migraine ad for Pfizer
- Lights, camera and community: AstraZeneca’s Alexion creates an original film to spotlight rare neurological disorder
- Takeda extends rare disease awareness campaign with patient-inspired imagery, stories
- UCB enlists real patients in new hidradenitis suppurativa campaign as it awaits Bimzelx decision
- Pharma, health and wellness judges named for 2024 Cannes Lions creative awards
MANUFACTURING
- The number of drugs in active shortage has reached an all-time high in the US, with 48 new medicines added to the list so far this year, according to a new report.
- Recipharm’s new CEO on ‘fast and furious’ changes, with eyes on GLP-1, biologics manufacturing
- Fujifilm invests $1.2B to expand North Carolina biomanufacturing facility
- Thermo Fisher to shrink plasmid manufacturing lab in California, lay off 74 workers
- Indian pharma receives FDA warning letter for barefoot employees and general ‘disrepair’
- Moderna halts African facility build as Covid-19 vaccine demand plummets
HEALTH TECH
- Funding for startups that sell reproductive and maternal health services to employers slumped after a pandemic-era spike — part of a digital health reset, Ngai Yeung reports.
- After hack, analysts are bracing for a ‘messy’ Q1 earnings from UnitedHealth Group
- Exclusive: Health insurance broker GoHealth trims jobs across departments
- Exclusive: Digital health venture firm Define Ventures hires industry vet Frank Williams
- Health tech startups raised $2.7B last quarter. It’s the lowest Q1 total in five years