Pharma: Page 2

Amgen data supports KRAS cancer drug, but survival benefit remains in question

Results from the company’s Phase 3 study show Lumakras outperformed chemotherapy. But that effect didn’t translate into patients living longer.

By Ned Pagliarulo • Sept. 12, 2022

Keeping track of changing payer formulary positioning and coverage

You need current, reliable data, but other factors are critical in assessing this information.

Sept. 12, 2022

Explore the 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

Bristol Myers gets FDA approval for new type of psoriasis drug

Sotyktu has been on the pharma’s top pipeline candidates and its clearance continues a string of positive regulatory news for the company.

By Jonathan Gardner • Updated Sept. 12, 2022

Moderna says US COVID-19 vaccine market could be worth $13B a year

The high end of the company’s estimates assumes a $100 price per dose and that half of all U.S. adults will receive a yearly booster.

By Christopher Newman • Sept. 9, 2022

Can biosimilars, after years of limited impact, finally make a mark in the US?

Seven years after the first copycat biologic drug arrived in the U.S., expected cost savings have been modest at best. The next few years will show whether the knockoff drugs can live up to their cut-price promise.

By Jonathan Gardner • Sept. 7, 2022

CDC backs updated COVID shots from Pfizer, Moderna

One day after the FDA’s authorization, the CDC recommended the companies’ omicron-targeted vaccines for most adults and children over 12 years old.

By Delilah Alvarado • Sept. 2, 2022

Novartis’ Bradner steps down as research head amid company shake-up

Jay Bradner, a well-known physician scientist who pushed to make Novartis more accessible to biotech startups, will be replaced by Merck executive Fiona Marshall in November.

By Ben Fidler • Sept. 1, 2022

FDA clears updated COVID-19 boosters from Pfizer, Moderna

The new shots, which are designed to better target circulating strains of omicron, could be available within days.

By Delilah Alvarado • Aug. 31, 2022

Pfizer lures first chief marketing officer from Verily

Drew Panayiotou led marketing efforts at Alphabet’s life sciences arm Verily, and his appointment is Pfizer’s third senior-level hire this year.

By Christopher Newman • Aug. 31, 2022

AstraZeneca, matching Lilly, reports positive heart failure data for diabetes pill

The new data position AstraZeneca to significantly expand use of Farxiga in heart failure and compete with Lilly and Boehringer Ingelheim’s rival drug Jardiance. 

By Jonathan Gardner • Aug. 29, 2022

Moderna sues Pfizer, BioNTech over COVID-19 vaccine technology

The biotech claims its rivals’ vaccine Comirnaty, one of the world’s top-selling pharmaceutical products, infringes on two patents covering its messenger RNA technology.

By Jonathan Gardner • Aug. 26, 2022

Pfizer follows GSK with positive Phase 3 results for RSV vaccine

In a pre-planned interim data analysis, Pfizer said its shot was strongly protective against severe disease and plans to submit the results to regulators this fall.

By Delilah Alvarado • Aug. 25, 2022

Novartis begins plans to spin off generic drug business

After reviewing multiple options including a possible sale, the Swiss drugmaker said spinning off Sandoz would give the division “greater freedom to operate” and capitalize on newly growing sales.

By Jonathan Gardner • Aug. 25, 2022

Safety worries spur Novartis to suspend drug dosing in Huntington’s trial

Researchers reported signs of nerve damage in patients treated with the drug branaplam, which is among the most advanced candidates now in testing.

By Jonathan Gardner • Aug. 24, 2022

Gilead breaks through with first approval for new HIV drug

European authorities cleared Gilead’s long-acting shot for patients whose HIV infection is resistant to other drugs. An FDA decision is expected by December.

By Jonathan Gardner • Aug. 22, 2022

Sanofi ends development of breast cancer drug in another blow to pipeline

The French drugmaker’s shares fell by more than 6% after the once promising treatment, called amcenestrant, failed its second major trial this year.

By Kristin Jensen • Aug. 17, 2022

UK approves Moderna’s two-pronged COVID-19 booster

Britain’s drug regulator is the first public health authority to clear a vaccine designed to fight omicron as well as the original strain of the virus. 

By Jonathan Gardner • Aug. 15, 2022

Novartis bid to repurpose rare disease drug for cancer falls short in third trial

A study testing Novartis’ canakinumab as an adjuvant lung cancer treatment missed its main goal, closing off an opportunity for an expanded approval.

By Ned Pagliarulo • Aug. 15, 2022

Messaging the right HCP at the right time via their electronic health record (EHR)

HCPs spend 3x the time in their EHR each day as they do online. How should that affect your approach to reaching HCPs?

Aug. 15, 2022

Pfizer’s new pneumococcal vaccine meets study goal in children

Pfizer, which competes with Merck in this market, plans to ask the FDA for an expanded approval of its 20-valent shot later this year.

By Delilah Alvarado • Aug. 12, 2022

Amgen’s low tax rates draw attention of top Democratic senator

Ron Wyden, D-Ore., is probing how Amgen paid an average effective tax rate of 12% over the past four years, well below the U.S. statutory rate of 21%.

By Ned Pagliarulo • Aug. 12, 2022

GSK, Pfizer, Sanofi shares drop amid Zantac litigation concerns

The companies could face liability related to their sales of the heartburn drug, which was withdrawn from the market in the U.S. and other countries after impurities related to a likely carcinogen were detected.

By Ned Pagliarulo • Updated Aug. 11, 2022

EQRx, in bid to compete, takes on AstraZeneca’s top seller in head-to-head trial

The study could be critical for a medicine EQRx plans to position as a competitor to Tagrisso. The drug is under review in the U.K., a first for EQRx.

By Kristin Jensen • Aug. 11, 2022

Novavax slashes revenue forecasts amid slow demand for COVID-19 vaccine

The biotech now expects about $2 billion in revenue in 2022, less than half its previous estimates, after sales fell sharply in the second quarter.

By Christopher Newman • Aug. 9, 2022

J&J’s head of R&D departs as pharma’s leadership turns over

Mathai Mammen is leaving to “pursue other opportunities,” J&J said in an abrupt announcement. William Hait, currently head of external innovation, will take Mammen’s place in the interim.

By Ned Pagliarulo • Aug. 9, 2022