The Latest
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Adeline Kon/BioPharma Dive
Record numbers of biotechs are going public. Here's how they're performing.
Reneo Pharmaceuticals and VectivBio made their Wall Street debuts on Friday, and two more cancer drug developers — the most active area for biotech IPOs over the past four years — joined the queue.
UPDATED: April 17, 2021 at 11:28 a.m. -
Permission granted by Relay Therapeutics
Relay buys AI startup to aid unorthodox drug discovery quest
The $85 million acquisition is an unusual and early step for a company like Relay, which went public last July and only just began clinical testing of its lead drugs last year.
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Erik S. Lesser via Getty Images
Merck, in latest COVID-19 setback, scraps one drug and pins hopes on another
The decision to end development of a medicine acquired in a $425 million deal last November is another disappointment for Merck's coronavirus effort, which once involved multiple drugs and vaccines.
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GlaxoSmithKline
GSK stops studies testing closely watched cancer immunotherapy
The British pharma will halt enrollment in two studies testing feladilimab alongside Merck's Keytruda, dealing another blow to the company's cancer drug pipeline.
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Elizabeth Regan / Industry Dive
Thermo Fisher to buy research contractor PPD in $17B deal
The deal values PPD at $47.50 a share, or about 24% over the company's closing price on April 13 — the day before The Wall Street Journal reported word of the planned acquisition.
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Getty Images
Cancer biotech Tango to go public through $350M SPAC deal
Gilead, which expanded its research collaboration with Tango last year, will take part in a related private investment along with more than a dozen high-profile backers.
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Phill Magakoe via Getty Images
The US paused use of J&J's vaccine. What happens next?
A call by regulators to stop J&J vaccinations won't dramatically disrupt supply in the U.S. But changes in labeling are possible, as is a renewed debate over vaccine hesitancy.
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Permission granted by Johnson & Johnson
US recommends pause in J&J vaccinations due to concerns over rare blood clots
Regulators identified rare and serious blood clots in six women vaccinated with J&J's shot. The reaction resembles a side effect linked to AstraZeneca's vaccine.
UPDATED: April 13, 2021 at 11:02 a.m. -
Permission granted by Gilead Sciences
Gilead stops Veklury study, citing enrollment challenges, changing treatment
The company said a multi-day infusion treatment that must be administered in healthcare settings no longer addresses an unmet need of non-hospitalized COVID-19 patients.
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Getty Images
Lilly, Arch join Deerfield in backing new gene therapy biotech Jaguar
Just two months after launching, Jaguar Gene Therapy has raised another $139 million for a preclinical pipeline aimed at gene-linked autism and diabetes.
UPDATED: April 13, 2021 at 11:15 a.m. -
BioPharma Dive
5 takeaways from AACR, one of the year's top meetings on cancer drugs
The American Association for Cancer Research's virtual conference featured fresh data on a new kind of cell therapy, an emerging immunotherapy target and a KRAS reboot.
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Cavazzoni to succeed Woodcock as the FDA's top drug reviewer
Cavazzoni will become director of CDER, a crucial position that Janet Woodcock, the FDA's acting commissioner and a contender for the full-time role, has filled for 24 of the last 27 years.
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Fotolia
Sage, Biogen drug reduces tremors but side effects could limit potential
Early Phase 2 data for a pill from the two companies' alliance appeared promising. But most patients had to cut their drug dose due to drowsiness.
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BioPharma Dive
Lilly gene-targeted drug shows potential for use across cancers
Study results presented at AACR showed Retevmo shrank tumors in nine different cancers, building a case for the type of tissue-agnostic label that only three other medicines have secured.
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Sanofi buys an mRNA startup in another bet on 'off-the-shelf' cell therapy
Tidal Therapeutics is the second biotech developing more convenient cell therapies that the French pharma has recently acquired as part of a broader expansion in oncology.
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Jacob Bell / BioPharma Dive
Provention Bio latest drugmaker flagged for 'deficiencies' in FDA approval application
While Provention executives think they can clear up the issues in a timely manner, shares in the biotech company slid sharply in response.
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Courtesy of AstraZeneca
Researchers lay out hypothesis for rare side effect linked to AstraZeneca vaccine
The EMA has reiterated the benefits of the shot outweigh the risks, but the safety concerns are another hurdle to the vaccine's rollout in Europe.
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Lilly claims promising finding in failed study of COVID-19 drug
Baricitinib, an oral tablet already authorized to treat COVID-19, fell short of goal in a large Phase 3 study. But Lilly also reported treatment led to a substantial reduction in death.
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Getty Images
With new data, Merck could be first to bring immunotherapy to early kidney cancer
Keytruda has become the first drug of its kind to succeed in the so-called adjuvant setting in renal cell carcinoma, continuing an industry-wide push to establish immunotherapy in earlier lines of cancer care.
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Getty Images
Biogen adds a late-stage prospect to its growing biosimilar business
A deal with Bio-Thera Solutions hands Biogen rights to a late-stage copycat of Actemra, Roche's blockbuster treatment for inflammatory diseases.
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Permission granted by Gilead Sciences
Gilead wins full approval for drug acquired in Immunomedics deal
Trodelvy, a key drug for Gilead's ambitions in oncology, is now fully approved to treat an aggressive, hard-to-treat form of breast cancer.
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Jacob Bell
FDA pushes back decisions on skin disease and arthritis drugs from Pfizer, Lilly
The delays offer further evidence regulators remain wary of the safety issues surrounding so-called JAK drugs like Pfizer's Xeljanz and Lilly's Olumiant.
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Courtesy of AstraZeneca
AstraZeneca's coronavirus vaccine possibly linked to rare blood clots, EMA says
Europe's drug regulator affirmed the benefits of vaccination outweigh the risks, but recommended the shot's label be updated to warn of the newly established side effect.
UPDATED: April 7, 2021 at 12:31 p.m. -
Dollar Photo Club
FibroGen admits misleading safety data for anemia drug, dimming prospects
In a surprise announcement, the company said data used to tout the safety of the anemia pill roxadustat included "post hoc changes" that executives only became aware of during regulatory review.
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Jacob Bell / BioPharma Dive
Acadia, with drug application rejected, calls out FDA for backtracking
According to Acadia, the FDA took issue with the main study used in its drug approval submission. That surprised the company, since regulators had never seemed concerned with the study's design.
