Takeda, in reversal, abandons cell therapy research

The Japanese pharmaceutical company, which had made cell therapy a priority a few years ago, aims to partner its work while prioritizing investments elsewhere.

A new biotech aims to get RNA drugs into the brain

Dublin-based Aerska launched on Wednesday with $21 million in seed funding and a technology designed to shuttle RNA interference medicines past the blood-brain barrier.

Galapagos to decide on fate of cell therapy business ‘within weeks’

The company has received a “limited number” of non-binding proposals, mostly from groups of financial investors, for a business that was once its primary focus.

FDA official’s comments spark Aurinia sell-off; Halozyme buys a biotech

George Tidmarsh criticized Aurinia’s lupus drug in a later-retracted social media post. Elsewhere, the FDA approved a new Novartis drug and two biotechs cut staff.  

Trump, Pfizer drug pricing deal short on details, possible impact

A pact to offer “most favored nation” prices to state Medicaid programs and via direct-to-consumer channels doesn’t affect those on commercial insurance or who won’t pay out of pocket.

Metsera strengthens case for Pfizer buyout with latest study data

In a Phase 2 trial, a drug at the center of the $4.9 billion deal matched the type of weight loss trajectory seen in testing of Eli Lilly’s Zepbound.

Crystalys debuts with $205M and plans for a better gout drug

The biotech is starting up with partial rights to a drug that’s approved in multiple Asian countries and its executives see as a superior version of the now-withdrawn gout medication Zurampic.

Emma Walmsley, big pharma’s first female CEO, to depart GSK

Walmsley, who helped push GSK to focus more exclusively on specialty medicines and oncology, will be succeeded by commercial head Luke Miels on Jan. 1. 

Star raises another $125M for its blood disease drug

Star hopes its drug, which is currently in late-stage testing, might prove a more convenient, longer-lasting alternative to standard therapies for Von Willebrand disease.

Moonlake shares crash on mixed study results for immune drug

Anticipated late-stage results in the skin disease hidradenitis suppurativa were described by analysts as “disappointing” and “undifferentiated,” erasing more than four-fifths of the company’s market value.

Key exemptions could limit impact of Trump’s pharmaceutical tariffs

Carve-outs for generics, European exports and companies onshoring drug production will likely shield most branded drugs from the 100% levies Trump announced Thursday.

Genmab to acquire closely watched cancer drug in $8B Merus buyout

The deal hands Genmab a drug that showed the potential in earlier testing to extend survival in head and neck cancer when added to Merck’s widely used immunotherapy Keytruda.

Why Xoma, a drug royalty firm, is hunting biotech ‘zombies’

The collapse in value of many biotechs over the past few years has created an opportunity for specialists like Xoma to “do the right thing” for the ecosystem and liquidate them, its executives say.

Crinetics drug to challenge pharma ‘Goliaths’; FDA, ARPA move to speed gene therapies

Crinetics’ acromegaly treatment will go up against several entrenched medicines. Elsewhere, Bristol Myers moved to sell Sotyktu online at a discount and regulators rejected a new version of Biogen’s Spinraza.

Lilly’s oral SERD gets FDA nod in advanced breast cancer

The clearance of Inluriyo is another development among a group of oral medicines aiming to supplant a widely used, injectable type of hormone therapy.

Trump sets tariffs on pharmaceuticals, trucks, furniture

The new levies, ranging from 25% to 100%, will go into effect Oct. 1, the president said Thursday.

Pharma’s next generation of antibodies takes a ‘more is better’ approach

A recent report from Back Bay Life Science Advisors shows a surge in testing of, and investment in, multifunctional antibodies that can hit two or more targets at once.

Disparity in vaccine access between states roils patients, providers

Recent changes to federal guidance on COVID vaccinations have providers worried about what’s to come. “We have opened a door to not using science to guide care,” one physician said.

Lilly stops trial of muscle-sparing obesity drug

Lilly’s decision comes as the FDA has indicated potentially higher approval standards for drugs meant to preserve muscle in people taking weight loss medicines. 

UniQure to seek approval of Huntington’s gene therapy after trial win

New study data showed treatment slowed signs of disease progression by 75% after three years, a finding that could have “massive effects on patients’ lives,” an investigator said.

Capricor readies revised FDA pitch for Duchenne cell therapy

Two months after its treatment for Duchenne-related cardiomyopathy was rejected, the company aligned with the agency on a framework that could support a clearance if upcoming study results are positive.

Acadia to scrap Prader-Willi drug after study setback

The trial failure removes from development a treatment Acadia acquired in a 2022 buyout and that was seen as a potential competitor to Soleno’s fast-selling Vykat. 

Sanofi Ventures banks $625M to back young biotechs, digital health startups

The French pharma’s venture arm will use the funds to back companies working in immunology, neurology, rare diseases and vaccines.

FDA, in unusual step, aims to repurpose old GSK drug as autism treatment

After reviewing existing published literature, the agency initiated the approval of Wellcovorin — which GSK stopped selling more than two decades ago — for a condition associated with autism.

Scholar Rock SMA drug rejected by FDA over manufacturing concerns

The denial sets back a drug Scholar Rock hopes to become part of a new standard of care for spinal muscular atrophy, treatment for which has changed dramatically over the last decade.