Page 2
-
Ultragenyx says Angelman therapy is working, but safety questions remain
Treatment appeared to result in functional and cognitive gains in people with the neurological disorder. Three participants experienced lower extremity weakness, however.
-
Biotech IPOs bounced back in first quarter, but backlog remains
Proceeds from biotech IPOs during the first three months of 2024 matched levels seen in the first quarters of 2019 and 2020, BioPharma Dive data show.
-
European regulator concludes no suicide link to obesity drugs
The decision clears a concern hanging over GLP-1 medicines like Ozempic since reports of suicidal ideation and self-harm among people taking the drugs surfaced in July.
-
Roche, Adaptimmune part ways on cell therapy research
The two companies have ended a collaboration that was struck in 2021 and focused on “off-the-shelf” cell therapies for cancer.
-
US sues Regeneron, alleging false price reporting on Eylea
The lawsuit claims the drugmaker didn’t disclose reimbursement to drug distributors for credit card fees, artificially inflating the reported price of the blockbuster eye drug.
-
Vertex to buy kidney disease drugmaker Alpine for $4.9B
A proposed $4.9 billion buyout of Alpine Immune Sciences would be the largest ever acquisition for Vertex and align with its "toolkit of technologies" approach to dealmaking.
Updated April 11, 2024 -
Emerging biotech
Century buys a startup, raises funding in cell therapy expansion
The biotech is acquiring Clade Therapeutics and its stem cell technology at a discount price, while adding $60 million via a private placement led by Bain Capital.
-
Deep Dive
New postpartum depression drugs are here. Diagnosis, treatment hurdles still stand in the way.
The first medicine approved for PPD, Sage’s Zulresso, never gained traction. The company is in the midst of launching its second, but long-standing challenges could slow uptake.
-
J&J, Rallybio partner on drug development for rare fetal condition
The biotech is working on a preventive therapy for the immune disorder, known as FNAIT for short, while J&J is studying its drug nipocalimab as a treatment.
-
Novartis pauses enrollment in some Kisqali trials to fix manufacturing
The company said the pause is necessary to meet regulatory limits on nitrosamine, but added it will not affect commercial supply nor regulatory review of the drug in early breast cancer.
-
RSV vaccines
Pfizer, with new study results, seeks to bring RSV shot to adults aged 18-59
The company plans to submit the trial data to regulators in a bid to win approval of its vaccine Abrysvo in adults as young as 18 years old.
-
Emerging biotech
PureTech launches Seaport, hoping to create Karuna 2.0
The startup is taking aim at anxiety with $100 million from high-profile biotech backers like ARCH, Sofinnova and Third Rock.
-
Private biotech funding rises as venture firms deploy cash
Twenty-six drugmakers closed fundraising rounds worth more than $100 million in the first quarter, according to HSBC data shared with BioPharma Dive.
-
Obesity drugs
Trial shows Wegovy can ease heart failure symptoms
The results were the second time Novo has shown its weight loss treatment can help with the condition, and may help it secure broader use of the drug.
-
Women want to participate in clinical trials. Lack of flexibility is still a problem.
Underrepresentation of women in clinical trials affects the resulting drugs that become available later. Even small changes could boost participation.
-
FDA approves CAR-T therapies from J&J, Bristol Myers for earlier myeloma use
The FDA quickly followed last week’s clearance of Bristol Myers’ Abecma with an OK for J&J’s Carvykti, but gave the rival treatments different labels.
Updated April 8, 2024 -
Boehringer Ingelheim to lay off staff amid biosimilar challenges
The German pharmaceutical company is “streamlining” its custom-facing teams behind Cyltezo, a copycat version of AbbVie’s immune disease drug Humira.
-
Amylyx to pull ALS drug from market in rare move
In the wake of a major trial failure, the company is withdrawing Relyvrio and cutting costs with a restructuring that involves laying off 70% of its employees.
-
Emerging biotech
Contineum prices biotech’s latest IPO, raising $110M for neuroinflammatory drugs
The offering keeps new biotech stock offerings on their strongest pace in three years, accompanying an uptick in private company funding.
-
J&J to acquire Shockwave Medical for $13.1B
The deal comes just over a week after The Wall Street Journal reported the companies were discussing a merger.
Updated April 5, 2024 -
Merck puts KRAS cancer drug competitor to the test
A Phase 3 study will compare Merck’s experimental KRAS inhibitor together with its immunotherapy Keytruda against Keytruda alone in lung cancer.
-
FDA approves new antibiotic for several hard-to-treat infections
Swiss pharma Basilea has won clearance for Zevtera after a long development journey, but is still searching for a commercial partner in the U.S.
-
Genmab buys ProfoundBio for $1.8B, adding to ADC dealmaking flurry
The buyout continues a surge in M&A for developers of antibody-drug conjugates and gives Genmab a potential competitor to a medicine AbbVie recently purchased in a multibillion-dollar acquisition.
-
Emerging biotech
Diagonal starts up with $128M to make better ‘activator’ antibody drugs
The startup claims to have a more efficient way to develop biologic drugs that treat disease by turning on cellular pathways, rather than blocking them.
-
Paragon’s hub-and-spoke biotech model yields another reverse merger
Oruka Therapeutics is the third startup from Paragon to go public since last year, and the second to do so by combining with another biotech.