Helping you make wiser investment decisions

Pharmaceuticals, health and wellness

Gilead, Merck and others slapped with ‘pay-for-delay’ lawsuits over lucrative HIV and cholesterol meds

A number of Big Pharma companies, including Gilead and Merck, engaged in what’s known as “pay-for-delay” deals, settling with up-and-coming generic rivals to stall their market entry and costing drug buyers hundreds of millions in lost savings as a result, a handful of high-profile new lawsuits claim.  Pharma watchers are likely familiar with so-called “pay-for-delay” […]

FDA’s ongoing review of accelerated cancer approvals targets 2 drugs from Secura and Aurobindo

The FDA initially targeted immunotherapies in its industry-wide review of accelerated drug approvals in oncology that failed to deliver in confirmatory trials. But the agency isn’t stopping there. The FDA is gathering an oncologic drugs advisory committee meeting on Dec. 2 to review whether two drugs should keep their conditional approvals, the agency said (PDF) Friday. […]

Merck will pay royalties on next-gen pneumococcal shot to settle Pfizer patent fight

Even before Merck and Pfizer won back-to-back FDA nods for their rival pneumococcal conjugate vaccines this summer, the companies were fighting it out in court over patents on the lucrative shots. With a new settlement, the pharma rivals are putting that dispute to rest. In a settlement this week in the U.S. federal court in Delaware, […]

CDMO Lonza strikes deal with Allarity Therapeutics to manufacture cancer drug candidate dovitinib

Allarity Therapeutics has worked diligently to develop Novartis’ failed cancer drug dovitinib. Now, as the Danish biotech anticipates the drug’s approval for metastatic renal cell carcinoma, it has lined up a manufacturing partner. Allarity has come to an agreement with CDMO giant Lonza, which will provide drug supply and regulatory support toward potential commercialization.  From its […]

Do not enter: Biogen reps banned from D.C.-area neurology clinics over controversial Alzheimer’s drug Aduhelm

Biogen has certainly faced an uphill battle trying to convince physicians to prescribe the drugmaker’s highly scrutinized Alzheimer’s drug Aduhelm. It doesn’t make it any easier if clinics won’t even let the company’s sales reps through the front door.  But that’s the case at the Neurology Center in Washington, D.C., which has gone so far […]

AstraZeneca lays out $360M for ‘next-gen’ manufacturing plant in Dublin

As AstraZeneca works to incorporate Alexion following its major buyout, the company is already breaking out its checkbook to invest in next-gen manufacturing capacity. On Tuesday, the U.K. drugmaker unveiled a $360 million investment at Alexion’s campus in Dublin, where it’ll construct an API facility for small molecules. The site will assist the company’s global manufacturing network […]

Good ad or bad ad? FDA quiz reminds docs about its Bad Ad program to police problematic advertising

True or false: Pharmaceutical companies are required to send drug ads to the FDA for approval before they’re used. It’s false—but you’d already know that if you took the FDA’s new interactive quiz to help promote its Bad Ad program. Now in its 12th year, the FDA’s Bad Ad program is promoting itself to healthcare providers to […]

Horizon partners with MIT for crowdsourced rare disease solutions, narrows to 5 finalists

Getting started is often the most difficult part—and that’s especially true in rare diseases and diagnoses. Patients and families often spend many years searching for their diagnosis starting point. For Horizon Therapeutics’ first innovation challenge, it took that struggle to heart and asked for technology-based rare disease solutions that result in faster or more accurate diagnoses. The […]

ESMO: Studies show COVID vaccines effective and safe for cancer patients, but jury still out for one key group

The world cheered last year when several COVID-19 shots were found to be highly effective in clinical trials. But, given that cancer patients were excluded from the studies, questions swirled over how well the shots would work in that group, especially for those on immunosuppressants.  Now, a set of studies released at the European Society for […]

ESMO: Pfizer, Astellas’ latest Xtandi survival data may shore up prostate cancer lead over J&J

Pfizer and Astellas have been in a toe-to-toe race with Johnson & Johnson in prostate cancer, managing to eke out slightly more indications and sales. Now, the pair is trumpeting key overall survival figures for Xtandi that could boost its prospects in men with a hard-to-treat type of the cancer.  A final analysis of Pfizer and […]

Pfizer recalls all Chantix lots nationwide over concerns of cancer-causing impurity

Pfizer’s headache with its popular smoking cessation drug Chantix is escalating. After the drugmaker halted global distribution this summer and then recalled more than a dozen lots in the U.S., the company is now recalling all lots nationwide. Pfizer on Thursday said it’s expanding its Chantix recall to the consumer level to include all batches […]

As Pfizer’s booster AdComm nears, FDA staffers say COVID vaccines are already working as intended

Ahead of the FDA’s advisory meeting to review Pfizer’s COVID-19 booster application, agency staffers voiced skepticism about the need to quickly roll out follow-up shots. As it stands, authorized vaccines are doing their job, the staffers said. In briefing documents ahead of Friday’s meeting, FDA reviewers said that while “some observational studies” suggest the efficacy of […]