Pfizer reported first-quarter 2021 revenue of $14.6 billion, an impressive 42 percent operational growth. The company’s Covid-19 vaccine revenue accounted for $3.5 billion of the total.

Germany’s CureVac, which is gearing up to publish results of a key Covid-19 vaccine trial, said U.S. export restrictions on key materials are making it impossible to predict the company’s short-term supply ramp-up in Europe.

The U.S. Food and Drug Administration greenlit AstraZeneca’s Farxiga (dapagliflozin) under priority review for the treatment of chronic kidney disease in patients at risk of progression with or without type 2 diabetes.

The U.S. Food and Drug Administration’s Oncologic Drugs Advisory Committee did not agree in a meeting to maintain the accelerated approval of Bristol Myers Squibb’s Opdivo (nivolumab) as a second-line treatment of hepatocellular carcinoma.

In a Complete Response Letter to Biogen, the U.S. Food and Drug Administration said the regulatory agency is unable to approve the company’s supplemental Biologic License Application for subcutaneously delivered Tysabri (natalizumab) for the treatment of relapsing multiple sclerosis, at least while the sBLA remains in its present form. 

Takeda’s non-small cell lung cancer (NSCLC) treatment Mobocertinib (TAK-788) is leading closer to regulatory approval after the U.S. Food and Drug Administration granted priority review to the New Drug Application. 

A U.S. Food and Drug Administration committee gave the nod to continue using Genentech’s checkpoint inhibitor Tecentriq in combination with chemotherapy to treat adults with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) whose tumors express PD-L1.

Placebo response is one of the most significant challenges faced by drug developers who are investigating new pain medications. According to a review of published chronic neuropathic pain trials, placebo responses have increased in magnitude over time, making it even more difficult to definitively demonstrate treatment advantage. Research has also shown that up to 60 percent of study participants may experience placebo-related analgesic responses and that these responses may be persistent.

Clarus Therapeutics Inc. and Blue Water Acquisition Corp. on April 27 announced a definitive business combination agreement that will result in Clarus becoming a publicly traded company. 

The U.S. Food and Drug Administration approved GlaxoSmithKline’s new checkpoint inhibitor, Jemperli (dostarlimab), for patients with recurrent or advanced endometrial cancer.