AstraZeneca the latest pharma to challenge drug pricing law

The drugmaker's lawsuit follows similar legal challenges from Merck & Co., Bristol Myers Squibb and Johnson & Johnson, among others. 

By Ned Pagliarulo • Aug. 25, 2023

FDA approves Novartis’ copycat of blockbuster Biogen drug

According to one analyst, the approval was the last hurdle keeping Sandoz’s Tyruko from directly competing in the U.S. market against Biogen’s inflammation-regulating medicine Tysabri.

By Jacob Bell • Updated Aug. 25, 2023

Explore the Trendline➔

Commercialization

New drugs for obesity and Alzheimer’s look set to become blockbusters, reshaping pharma marketing strategies just as many current top-sellers near looming patent cliffs.

By BioPharma Dive staff

Boehringer sues to block US drug price program

The pharma’s suit, which claims Medicare’s new power to negotiate certain drug prices is unconstitutional, comes days before the agency will reveal the first 10 medicines to be included under the plan.

By Ned Pagliarulo • Aug. 22, 2023

Amazon Pharmacy expands insulin manufacturer coupons

The new coupons include some of the most commonly prescribed diabetes drugs from Eli Lilly, Novo Nordisk and Sanofi.

By Rebecca Pifer • Aug. 17, 2023

Dexcom, Abbott ramp up DTC marketing in fight for growing diabetes market

As insurers cover continuous glucose monitors for more people, device makers are taking a page from the pharma marketing playbook.

By Elise Reuter • Aug. 17, 2023

Amylyx ALS drug sales tick higher after fast US launch

In Europe, however, the biotech is appealing a negative decision from regulators that has for now blocked its path to market there.

By Ned Pagliarulo • Aug. 11, 2023

Novartis sickle cell drug’s approval formally revoked by EU regulators

The company said it would withdraw the drug, Adakveo, from the EU market after the European Commission endorsed an earlier EMA recommendation.

By Ned Pagliarulo • Aug. 4, 2023

With OTC birth control approved, access battles have just begun

Perrigo received the first FDA approval for an over-the-counter birth control pill. Now, its global VP of women’s health says the company is working on the next challenge — affordability.  

By Karissa Waddick • July 31, 2023

Apellis faces safety doubts for fast-selling eye drug

At a medical meeting, the company confirmed seven cases of a rare, but severe, side effect have been reported following treatment with its geographic atrophy drug Syfovre.

By Ben Fidler • Updated July 31, 2023

Apellis shares sink on reports of rare side effects with new vision loss drug

An organization of retinal specialists flagged six cases of severe eye inflammation from commercial use of Syfovre. Apellis says the drug’s safety profile is consistent with testing.

By Ben Fidler • July 17, 2023

More convenient form of Roche MS drug succeeds in study

The under-the-skin formulation of Ocrevus can be administered in 10 minutes, versus a longer period for the current intravenous version.

By Kristin Jensen • July 13, 2023

EMA expands probe of possible suicide risk to popular weight loss, diabetes drugs

The European drug regulator says it now has 150 reports of possible cases involving self-injury and suicidal thoughts among people taking GLP-1 medicines like Ozempic.

By Kristin Jensen • July 12, 2023

Illumina hit by EU with maximum fine for Grail acquisition

The European Commission called Illumina’s closing of the deal without its approval an “unprecedented” move that undermines its system for regulating the competitive landscape.

By Susan Kelly • July 12, 2023

Bausch + Lomb bulks up OTC business with J&J deal

The eye care company has become an active acquirer under new CEO Brent Saunders, buying an eye drop product line one week after purchasing several medicines from Novartis.

By Ned Pagliarulo • July 6, 2023

With FDA approval in hand, BioMarin lays out plan to sell $2.9M gene therapy

The agency granted a long-awaited clearance last Thursday, but unexpected aspects of the hemophilia treatment’s label had some investors worried about its commercial prospects.

By Jacob Bell • June 30, 2023

Amylyx’s ALS drug gets pushback from European regulators

An EMA committee expressed concern with the main study meant to show Amylyx’s drug is safe and effective. The company now plans to ask for a re-examination of its approval application.

By Jacob Bell • June 23, 2023

As Illumina’s deSouza departs, will Grail go next?

The CEO’s resignation signals a change of direction, as anti-trust regulators order Illumina to divest the liquid biopsy unit.

By Susan Kelly • June 12, 2023

Bayer launches precision health unit in latest digital health venture

The pharma company said it will work with startups and other digital health companies as it builds out the consumer-focused business unit.

By Emily Olsen • June 1, 2023

2023 Veeva trends in HCP omnichannel engagement report

Boost campaign effectiveness by 23% by synchronizing sales and marketing.

May 30, 2023

House lawmakers, PBM lobby spar over committee hearing

At the latest congressional inquiry into pharmacy benefit managers, lawmakers argued the middlemen profit at the expense of patients and taxpayers.

By Rebecca Pifer • May 25, 2023

Amylyx’s ALS drug again surpasses Wall Street expectations

Revenue from the biotech’s ALS therapy Relyvrio totaled $71.4 million in the first quarter, well above analyst estimates and helping the company turn a profit only months into the drug’s launch.

By Jacob Bell • May 11, 2023

Here’s what will change when the COVID public health emergency ends

Vaccines, which have been crucial to curbing the virus’ spread, will remain free for the vast majority of people in the U.S., but over-the-counter tests will no longer be covered for most.

By Shannon Muchmore • May 10, 2023

Abortion providers in 3 states sue over mifepristone restrictions

The lawsuit seeks to remove safety restrictions on mifepristone or, alternatively, prevent further altering of access to the drug.

By Sydney Halleman • May 9, 2023

Pfizer turns focus to new drugs as COVID vaccine revenue falls

The drugmaker beat Wall Street’s first quarter forecasts despite a sales drop that puts pressure on it to succeed with upcoming market launches.

By Jonathan Gardner • May 2, 2023

Lilly plans dash to market for weight loss drug after trial win

The drugmaker will use a priority review voucher in a bid to secure FDA approval of Mounjaro in obesity by late this year or early next.

By Jonathan Gardner • April 27, 2023