Pharma

FDA panel endorses second shot for adults who received J&J vaccine

Agency advisers unanimously supported offering a second dose of J&J's coronavirus vaccine to adults who previously received it, though guidance could change as regulators evaluate mixing boosters.

By Ben Fidler • UPDATED: Oct. 15, 2021 at 4:03 p.m.

AstraZeneca immunotherapy combo extends survival in liver cancer trial

The results are a rare positive result for AstraZeneca's experimental drug tremelimumab, which has come up short in a handful of other studies and cancer types.

By Ned Pagliarulo • Oct. 15, 2021

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Trendline

Inside the race to bring coronavirus vaccines to the world

More than a dozen shots are cleared for use in some fashion around the world. Producing enough supply and addressing the spread of coronavirus variants are the next challenges. 

By BioPharma Dive staff

Merck advantage grows as FDA approves Keytruda for first-line cervical cancer

The company's immunotherapy is the only drug of its type cleared for advanced cervical cancer. Others are being tested, however. 

By Ned Pagliarulo • Oct. 14, 2021

NIH study finds mixing COVID-19 boosters increases immune response

Results suggested Pfizer's and Moderna's vaccines may serve as a more potent booster for those who initially received Johnson & Johnson's shot, although data are limited and preliminary.

By Shoshana Dubnow • Oct. 13, 2021

Lilly drug cleared by FDA for wider use in breast cancer

Verzenio now has an expanded approval for treatment of a common form of early cancer, although the label granted by FDA places some limits on use.

By Kristin Jensen • Oct. 13, 2021

AstraZeneca builds case for long-acting COVID-19 drug, but is it too late?

The British drugmaker could soon become the first with both a marketed vaccine and treatment for COVID-19, a notable achievement. Yet competition has blunted the potential impact of each of them.   

By Ben Fidler • Oct. 12, 2021

Adamas, Flexion sell for $825M combined as biotech's dealmaking pace picks up

After lagging for months, M&A has accelerated over the past five weeks. The latest evidence comes from two deals based largely on future drug sales.

By Jonathan Gardner • Oct. 11, 2021

Merck, Ridgeback seek US clearance of first oral COVID-19 drug

The two partners have officially filed for emergency authorization of their antiviral pill. It's not yet clear whether vaccine recipients would be eligible for treatment, however.

By Ben Fidler • Oct. 11, 2021

Pfizer officially seeks FDA clearance for coronavirus vaccine in kids

The companies' application starts a pressure-packed FDA review that could open up COVID-19 shots for tens of million Americans between the ages of 5 and 11.

By Shoshana Dubnow • Oct. 07, 2021

Bristol Myers' top autoimmune drug prospect takes a hit in mid-stage trial

The failure of the pharma's TYK2 blocker in the first of two ulcerative colitis studies is a setback for a treatment that's expected to become a top-seller.

By Ben Fidler • Oct. 07, 2021

J&J heats up RSV race with new vaccine data

The company's candidate is one of two to enter late-stage testing for a respiratory virus that causes hundreds of thousands of hospitalizations a year.

By Jonathan Gardner • Oct. 04, 2021

Gilead wins approval of CAR-T therapy in adult leukemia

Tecartus, Gilead's second cell therapy on the market, is the first CAR-T treatment to be cleared for use in people older than 18 with ALL.

By Ned Pagliarulo • UPDATED: Oct. 4, 2021 at 12:29 p.m.

GSK, Merck KGaA end cancer drug partnership after study results disappoint

Bintrafusp alfa was highlighted by GSK as a potential blockbuster drug as recently as January. Negative findings in two trials, however, led the companies to unwind their research collaboration.

By Ned Pagliarulo • Oct. 01, 2021

Merck says antiviral pill effective against COVID-19, lifting hopes for first oral drug

The drugmaker, along with partner Ridgeback Biotherapeutics, plan to ask the FDA for emergency authorization "as soon as possible" following results so striking that testing was stopped early. 

By Ben Fidler • Oct. 01, 2021

Sanofi claims positive early data for mRNA COVID shot, but pivots to flu instead

With Pfizer's and Moderna's vaccines broadly used, Sanofi says it will focus on its protein-based coronavirus candidate. The French pharma sees more promise for its mRNA work in influenza.

By Jonathan Gardner • Sept. 28, 2021

Eisai, Biogen to test FDA by asking for approval of second Alzheimer's drug

The Japanese pharma and Biogen partner is filing an application for an accelerated OK of lecanemab, which works similarly to the companies' controversially cleared Aduhelm.

By Ned Pagliarulo • UPDATED: Sept. 28, 2021 at 7:47 a.m.

FDA lifts hold on GeneTx, Ultragenyx study of Angelman therapy

The hold, which was put in place during the fourth quarter last year, came after five patients in an early trial experienced muscle weakness following treatment.

By Shoshana Dubnow • Sept. 27, 2021

As FDA scrutinizes immunotherapy approvals, Merck says Keytruda extends survival in liver cancer trial

Phase 3 results showed Merck's drug improved overall survival versus placebo, which should lessen pressure for a market withdrawal in the indication.

By Jonathan Gardner • Sept. 27, 2021

Sponsored by SGS

Charged aerosol detection: Chromatographer's magical tool to unravel the invisible in biologics

The discovery and development of next generation therapeutics will drive the availability and use of Biologics to meet the unmet medical needs, never imagined before.

By Yena Patel, Sahil Shah and Bart Byczynski • Sept. 27, 2021

Insurers sue Merck for 'monopolistic scheme' to delay generics of blockbuster cholesterol drug

The suits allege an agreement between Merck and a generic manufacturer kept low-cost versions of the drugmaker's widely used Zetia off the market for years.

By Samantha Liss • Sept. 24, 2021

AstraZeneca strikes deal with university spinoff to turn RNA into drugs

The British drugmaker is investing in VaxEquity, a biotech founded last year to explore a twist on the mRNA technology that Moderna and BioNTech have made famous.

By Ned Pagliarulo • Sept. 23, 2021

Chinese drugmaker Clover says vaccine prevents COVID-19 in large trial

Positive results from Clover's Phase 3 study could mean another coronavirus vaccine option for the many countries still grappling with short supplies.

By Jonathan Gardner • Sept. 22, 2021

US buying 500M more doses of Pfizer coronavirus vaccine for donation to world

Under pressure to help other countries access vaccines, Biden is doubling his administration's planned donation to 1 billion doses, although delivery will extend through September of next year. 

By Ned Pagliarulo • Sept. 22, 2021

Second dose of J&J's coronavirus vaccine increases protection, company says

Long-awaited results from a Phase 3 study run by J&J could support use of a booster dose, although the drugmaker has not officially applied for FDA clearance yet.

By Shoshana Dubnow • Sept. 21, 2021

Seagen, Genmab win speedy FDA approval for cervical cancer drug

Tivdak, a type of drug known as an antibody-drug conjugate, is the fourth approved medicine for Seagen and its third to reach market since December 2019.

By Jonathan Gardner • Sept. 21, 2021