Pharma: Page 2

As trials progress, FDA weighs COVID-19 vaccine authorizations for children

An advisory panel could not reach consensus on how long or large trials in young children should be. Some experts argued falling infection rates might mean vaccination of kids under 12 is unnecessary.

By Jonathan Gardner • June 11, 2021

Bristol Myers says CAR-T therapy beat chemo, transplant in lymphoma study

The results could help support taking CAR-T therapy into earlier lines of cancer treatment, a long-held goal for the complex cellular drugs. 

By Ned Pagliarulo • June 10, 2021

Explore the Trendline➔

Trendline

The expanding world of RNA therapies

Vaccines from BioNTech and Moderna proved the power of messenger RNA in medicine. A growing field of RNA-targeting therapies is advancing alongside them.

By BioPharma Dive staff

'The lights are no longer green': Antitrust regulators reassess pharma deals

The FTC and its counterparts abroad are rethinking their approach to drugmaker acquisitions. Past scrutiny offers clues to where they may look next.

By Jonathan Gardner • June 10, 2021

US bets $1.2B on Merck's last hope for a COVID-19 drug

Though most of Merck's COVID-19 efforts have come up short, its antiviral pill could still have a role, as signaled by the U.S. government's sizable financial commitment.

By Ben Fidler • June 09, 2021

Biogen Alzheimer's approval could open the door for similar drugs

Approval of Aduhelm sets a precedent that could enable some drugs, like Eli Lilly's drug donanemab, to advance quickly and cause other previously sidelined ones to get a second look.

By Jonathan Gardner • June 09, 2021

Novo keeps price in line with FDA approval of second obesity shot

Wegovy, a weekly drug, joins daily Saxenda in the pharma's portfolio, which could soon be under pressure from an experimental Lilly medicine.

By Jonathan Gardner • June 07, 2021

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.

By Jonathan Gardner • June 04, 2021

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.

By Ned Pagliarulo • June 04, 2021

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. 

By Ben Fidler • June 03, 2021

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.

By Ned Pagliarulo • June 03, 2021

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.

By Jonathan Gardner • June 03, 2021

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.

By Jonathan Gardner • May 25, 2021

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.

By Jonathan Gardner • May 24, 2021

Coronavirus variants threaten to undermine another Lilly COVID-19 drug

One month after Lilly's first coronavirus antibody was pulled from market, the U.S. government stopped distributing its other treatment in two states.

By Ben Fidler • May 24, 2021

Pfizer, BioNTech to send EU up to 1.8B coronavirus vaccine doses

The deal, which the companies and the bloc have been negotiating for weeks, will significantly expand on the current contract for 600 million shots.

By Kristin Jensen • May 20, 2021

Off-the-shelf CAR-T, a Tagrisso rival and the next breast cancer drugs

Study abstracts for drugs from Allogene, EQRx, Sanofi and Lilly drew early interest and helped set the stage for the meeting. 

By Ben Fidler , Ned Pagliarulo • May 20, 2021

Closely watched Bristol Myers immunotherapy shows benefit in melanoma

Study results prove, for the first time, that a drug blocking the protein LAG-3 can improve on another immunotherapy.

By Ned Pagliarulo • May 19, 2021

Humira patents take center stage as House panel targets AbbVie pricing

CEO Richard Gonzalez defended the company's practices, arguing its profits help spur innovation: "The products that are on the market today pay for the products of the future," he said.

By Jonathan Gardner • May 18, 2021

Bristol Myers pays Agenus $200M for drug aimed at top immunotherapy target

The pharma acquired rights to an experimental antibody medicine that blocks a protein, called TIGIT, that's become a focus for several cancer drugmakers.

By Ned Pagliarulo • May 18, 2021

Novartis challenge to Amgen's Enbrel patents ends at Supreme Court's door

The top court declined to hear Novartis' appeal of an earlier federal ruling in Amgen's favor, likely preventing biosimilar competition until 2029. 

By Ned Pagliarulo • May 18, 2021

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. 

By Jonathan Gardner • May 17, 2021

Sanofi, GSK say revamped coronavirus vaccine is strong enough for final test

The two drugmakers, set back last December after an earlier version underperformed, reported positive results from a Phase 2 study.

By Ned Pagliarulo • UPDATED: May 17, 2021 at 6:38 p.m.

Merck, with new breast cancer data, aims to rebound from FDA rejection

Study results could address concerns raised by FDA advisers who recently voted against approval of Keytruda in patients with early-stage breast cancer.

By Ben Fidler • May 13, 2021

Biogen licenses a stroke drug from Japanese drugmaker TMS

The drug, which Biogen had an option to license, is one of two in the biotech's pipeline for a condition that has had few new treatments developed. 

By Kristin Jensen • May 12, 2021

Amgen asks FDA for approval of key asthma drug

Tezepelumab is one of Amgen's top experimental medicines and a U.S. OK would help its efforts to offset revenue declines from its aging blockbusters.

By Ned Pagliarulo • May 10, 2021