Approvals & Launches

The drug maker said the program would allow for continued reimbursement when patients change insurance plans. A Sangamo-partnered gene therapy for hemophilia A is also in the works.

Revlimid and Eliquis beat expectations in the first quarter, but the products have dwindling exclusivity, making new drugs the main focus for Bristol. So the company will reinvest cost savings in R&D.

Some patients have already been prescribed the new drug for pulmonary arterial hypertension but Merck & Co. did not provide any sales or guidance. 

CEO Paul Hudson says that the French major will continue to progress early-stage cancer projects despite jettisoning some oncology programs in favor of reallocating much of its research budget to immunology.

Sales of the company’s new drugs have a lot of growing to do to make up for older products’ declines, but Biogen highlighted signs of strength for new launches in its Q1 report.

The company is targeting around 200 centers that treat the vast majority of the few thousand pediatric low-grade glioma patients who are candidates for the RAF-targeting drug.

Execs Richard Adcock and Patrick Soon-Shiong told Scrip the company sees an addressable US population of about 20,000 and is aiming for ease of physician adoption.

Bristol Myers Squibb’s head of major markets, Monica Shaw, wants to improve patients’ access to lifesaving therapies. And the group has several new products ready to roll.

The US FDA cleared Roche’s supplemental approval request for ALK inhibitor Alecensa in ALK-positive non-small cell lung cancer following tumor resection.

The top 10 biggest share price winners and losers in Q1 from Evaluate show the investor frenzy for obesity drugs continues, while companies with governance doubts see shareholders retreat.

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

The French drugmaker has identified education as a key challenge ahead of its June action date for the huge-selling IL4/IL-13 inhibitor in the lung condition. An approval would make it the first biologic for the disease.

US market access senior VP Tom Rainey talks to Scrip about the upcoming launches of biosimilar versions of Humira and Stelara.

The company initiated a rolling submission with the US FDA for mirdametinib, a MEK inhibitor that is poised to be its second commercial product for a rare disease.

Sanofi India managing director Rodolfo Hrosz talks to Scrip about the company’s refreshed India strategy including in the competitive diabetes segment, which is expected to see a flurry of new product activity. While Soliqua has hit the market, all eyes are also on Novo Nordisk’s Awiqli and Cipla’s partnered inhaled insulin in the wings.

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.