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Bristol Myers sued over delayed approval of cancer cell therapy

A bank representing former Celgene shareholders claims Bristol Myers did not work diligently to secure FDA clearance of Breyanzi, one of three drugs covered by a $6.4 billion agreement between the two companies.

Alexion, AstraZeneca executives switch roles amid $39B buyout

Marc Dunoyer, the U.K. drugmaker's longtime finance chief, will move over to a strategy role and run Alexion as a rare disease unit within AstraZeneca.

An AstraZeneca, Merck drug slows the return of genetic breast cancer. Will testing speed up?

New study results could make Lynparza a standard adjuvant treatment for people with an inherited form of breast cancer — as long as they know they have it. 

Novartis prostate cancer drug extends survival in key test of radiopharmaceutical therapy

Results from the Phase 3 trial, which Novartis plans to use to ask for approval, help validate the pharma's bet on the therapy's original developer, Endocyte.

Biotech venture capital still booming as venBio raises another $550M

VenBio has previously invested in a range of treatment areas and technologies, including cell and gene editing companies like Precision Bio and Artiva. 

Deep Dive

Trump tax law cut what US drugmakers owed. Now they fear an increase.

The 2017 law saved pharmaceutical companies billions of dollars, BioPharma Dive found. Executives are now fiercely opposing tax hikes proposed by President Biden, claiming they've since boosted domestic investment. 

Bayer buys a biotech and its offshoot in bet on radiopharmaceuticals

The German pharma will add an experimental prostate cancer medicine to its pipeline through the deal, which reflects growing industry interest in the field.

Former FDA official Abernethy joins Google health spinoff

The agency's former acting CIO pushed development of real world evidence as well as improved data sharing. At Verily, she'll head up the unit's clinical research business.

Orchard abandons promising gene therapy for rare immune disorder

The U.K. biotech deprioritized the therapy last year, despite positive results in clinical testing that were recently published in a top medical journal.

MorphoSys to buy Constellation in $1.7B deal, aided by unusual funding

Royalty Pharma will effectively fund MorphoSys' acquisition of the cancer biotech through a separate agreement to buy MorphoSys' shares of royalties on several marketed and experimental medicines. 

Alkermes prepares for uncertain launch as FDA finally clears schizophrenia drug

Lybalvi is meant to be as effective as marketed antipsychotics but without the weight gain patients typically experience. Alkermes will introduce the drug into a competitive market, however.

Amgen pays $400M for an eczema drug, putting faith in an old partner

A deal with Kyowa Kirin gives Amgen rights to an experimental treatment aimed at an autoimmune target that has drawn interest from multiple drugmakers.

Sanofi rare disease drug hits another setback

The French pharma halted a late-stage trial of venglustat, one of its priority drug candidates, in a type of kidney disease, months after stopping testing in Parkinson's.

EQRx readies a lower-cost alternative to pricey cancer immunotherapies

The biotech and its partner CStone disclosed Phase 3 results in lung cancer that support approval plans for a drug similar to treatments like Merck's Keytruda, but would be priced at a fraction of the cost.

In first, FDA approves KRAS-blocking cancer drug from Amgen

For decades, scientists have tried unsuccessfully to target the KRAS gene, which is often mutated in lung, colon and pancreatic cancers. Lumakras is the first drug proven effective.

UPDATED: May 29, 2021 at 12:35 p.m.

Centessa raises $330M in third largest biotech IPO this year

The public offering follows just three months after Centessa, created from the merger of 10 Medicxi-backed drug startups, launched with $250 million in venture funding.

'A hugely consequential decision:' How Biogen's Alzheimer's drug came to face the FDA

The FDA's decision to approve aducanumb could have far-reaching consequences for patients, Biogen and Alzheimer's research. Here's how the drug's review came about. 

Vir, GSK win US nod for another COVID-19 antibody drug as rival falters

Vir's sotrovimab arrives months after similar treatments from Eli Lilly and Regeneron. But the therapy could still play a role due to its apparent potency against variants that have challenged Lilly's drugs.

FDA restricts use of Intercept drug due to liver injury risk

An investigation linked the drug to severe injuries in about two dozen patients, leading the agency to add a new contraindication to the label.

UniQure moves Huntington's gene therapy to next phase of key trial

Safety monitors cleared the company to test a higher dose after reviewing data from 10 patients, providing some hopeful news after recent setbacks for experimental drugs targeting the genetic disease.

Lyell aims to follow Juno, Sana as Wall Street cools to biotech IPOs

The ambitious cell therapy developer, which has already raised nearly $1 billion from investors, will test the IPO market just as the pace and performance of recent biotech offerings have slowed considerably.

UK drug contractor to be sold to private equity firm in $1.4B deal

Through a subsidiary, The Carlyle Group will pay a 27% premium to acquire Vectura, a CDMO that specializes in inhaled medicines.

ICER, vocal critic of drug company pricing, turns scrutiny to insurers

The watchdog group plans to examine how cost sharing can hurt access to care, but it won't assess some of the most controversial insurer practices.

Moderna, with new results, set to seek vaccine clearance for young teens

The biotech's shot was strongly protective against COVID-19 in a study of 12- to 17-year-olds, a finding that could soon make it the second vaccine available for adolescents in the U.S.

J&J's new cancer drug leads a growing pipeline of dual-targeting antibodies

Pharma and biotech companies alike see potential in using bispecific antibodies for hard-to-treat cancers like leukemia, myeloma and solid tumors.