The submission of additional information, upon the request of the US regulator, has delayed the action…

Germany’s science and technology company Merck KGaA today announced its investment in SynSense (formerly…

Late Wednesday, the US Food and Drug Administration said it has granted accelerated approved for Tabrecta…

Privately-held Italian pharma group Mediolanum Farmaceutici has acquired the French immuno-oncology specialist…

COVID-19 is having varying effects on different markets within healthcare, with drug delivery systems…

Shares of Dr Reddy’s Laboratories rose more than 2% to 3,936.35 rupees, after the Indian drugmaker…

US pharma major Bristol-Myers Squibb saw its revenue reach $10.8 billion in the first quarter of 2020,…

The US Food and Drug Administration has granted accelerated approval for Retevmo (selpercatinib) capsules…

US pharma major AbbVie has finally completed its $63 billion acquisition of Ireland-incorporated Allergan,…

US biotech firm jCyte Inc has entered into a licensing agreement with Japanese ophthalmology specialist…

Gilead Sciences scored a massive win earlier this week with its first positive data readout for investigational candidate remdesivir in treating patients with severe COVID-19. Gilead already has its own supply of the drug humming in anticipation of high demand, but opportunities are out there for a partner to join in. 

AbbVie may be working through COVID-19, but it's pressing ahead with its Allergan merger, too—and taking stock of products hit by pandemic lockdowns. That puts Allergan’s aesthetics business top of mind, but AbbVie CEO Rick Gonzalez figures customers are ready and able to return quickly for treatment.

Days after U.S. officials reported the first positive controlled data for Gilead's remdesivir in COVID-19, the FDA has given the drug an emergency use authorization.

Novartis is using familiar faces—real patients from its Cosentyx TV commercials—to thank healthcare workers and promise support for patients. It’s a shift away from product-centered TV ads as Novartis adjusts its Cosentyx DTC effort during the COVID-19 crisis to highlight resources for patients, the drugmaker said.

Roche scored a major win with the FDA's backing for its COVID-19 antibody tests last week in a field marked by products of questionable quality. Now, to cover its booming production goals, Roche plans to infuse nearly half-a-billion dollars into its German manufacturing facility. 

While Gilead has yet to present a marketing plan for remdesivir—much less a price—ICER figures the COVID-19 drug could be cost-effective at up to $4,460 per patient. That means it could easily rake in blockbuster sales this year, at least theoretically.

Gilead made waves on Friday with its emergency FDA approval for remdesivir quickly on the heels of a controlled trial data release. But while it’s an important first step, other COVID-19 medicines will likely be coming down the line, analysts wrote.

Even a pandemic can’t slow down Seattle Genetics and Astellas' new bladder cancer treatment Padcev, which "blew out sales expectations" for the first quarter, analysts said. And now, they're jacking up their long-term sales estimates for the drug as a result.

After his surprise removal from HHS’ Biomedical Advanced Research and Development Authority—a key agency partnered with pharma companies on COVID-19 drugs, vaccines and diagnostics—former Director Rick Bright is alleging whistleblower retaliation by HHS leadership. 

With its multibillion-dollar restructuring plan in the rearview mirror, Teva is pinning its future growth on two of its branded meds with high hopes. But generics are still central to the Israeli drugmaker's business, and increased demand due to COVID-19 gave Teva a welcome gift in the first three months of the year.

Biogen has had a rocky road with its controversial Alzheimer's disease candidate aducanumab, resurrected late last year. But despite postponing the drug's FDA filing half a year, Biogen is still moving forward with plans to scale up production if aducanumab eventually passes muster.

Bristol Myers Squibb CEO Giovanni Caforio credited COVID-19-related stocking for high sales of some products in the first quarter, including Eliquis, a blood thinner that's being snapped up to reduce clotting risk in patients with the virus. But the pandemic has limited access to oncology clinics and other non-COVID-19 services, raising challenges that could impact sales later this year.

Global Blood Therapeutics' sickle cell disease medicine Oxbryta got off to a hot start after a November FDA approval. But early in its launch, execs now say they're seeing a "clear headwind" from the COVID-19 pandemic. Lately, new patient starts have tanked by 60%, CEO Ted Love said.

Gilead Sciences' remdesivir, now called Veklury, has won a fast Japanese nod in SARS-CoV-2. The Big Biotech's scouting licensing partners to ramp up supply around the world. Eli Lilly has signed on China's Junshi Biosciences to develop neutralizing antibodies against the novel coronavirus. And more.

When Gilead Sciences scored a groundbreaking FDA emergency use authorization for COVID-19 therapy remdesivir, the company made the unusual move of handing distribution rights to the U.S. government. But the federal rollout has gotten off to a rocky start. 

Unlike its first U.K. reimbursement negotiations, Roche’s HER2 antibody-drug conjugate has won quick National Institute for Health and Care Excellence backing for routine NHS coverage to prevent HER2-positive breast cancer from returning after surgery in the so-called adjuvant setting.

Gilead Sciences has captured worldwide attention with its COVID-19 antiviral, remdesivir, cleared late last week by the FDA—not all of it welcome. With bad actors targeting companies at the head of the spear in the pandemic response, Gilead may have found itself in their sights.

Only days after former BARDA chief Rick Bright filed a whistleblower complaint alleging retaliation by the Trump administration, the U.S. Office of the Special Counsel has recommended his temporary reinstatement, the New York Times reports.

The number of confirmed coronavirus cases in Germany increased by 1,251 to 168,551, data from the Robert Koch Institute (RKI) for infectious diseases showed on Saturday.

China reported one new coronavirus case for Friday, unchanged from the day before, data from the national health authority showed on Saturday.

China will reform its disease prevention and control system to address weaknesses exposed by the coronavirus outbreak, a senior health official said on Saturday.

Chinese regulators have approved Novartis' Mayzent to treat relapsing multiple sclerosis in adults, the Swiss drug maker said in a statement on Saturday.

Russian authorities said on Saturday they had recorded 10,817 new cases of the coronavirus in the last day, pushing the nationwide tally to 198,676.

Tokyo reported 36 new cases of coronavirus infections on Saturday, TV Asahi said, three less than a day earlier and the seventh consecutive day that new infections have remained below 100.

Indonesia reported on Saturday 533 new coronavirus infections, the biggest daily increase, taking the total number to 13,645, health ministry official Achmad Yurianto said.

Malaysia health authorities on Saturday reported 54 new coronavirus cases for a total of 6,589.

A 5-year old boy has died in New York from a rare inflammatory syndrome believed to be linked to the novel coronavirus, highlighting a potential new risk for children in the pandemic, Governor Andrew Cuomo said on Friday.

Spain's daily death toll from the coronavirus fell to its second lowest since mid-March on Saturday, as half the country prepared to move to the next phase of an exit from one of Europe's strictest lockdowns.

The U.S. Food and Drug Administration (FDA) on Saturday approved emergency use authorization (EUA) to Quidel Corp for the first COVID-19 antigen test.

Closing out another year at BiotechDueDIligence, thank you for following along! Enjoy another round-up of scientific and medical journal articles driving the conversation and newsflow in biotech.There's lots of great #immunology in @sciencemagazine this week! @JSRustenhoven & @jonykipnis (@kipnislab @UVA) author a fascinating Perspective on how immune cells bypass the blood–brain barrier!https://t.co/6QjcNxU0p6 pic.twitter.com/njjnrn9Yej— Seth Thomas Scanlon (@ImmunoEditor) December 20, [...]

Important paper out on #Wuhan #nCoV2019 via @biorxivpreprint96% sequence identity to a bat #coronavirus~80% sequence identity to SARS~95% AA sequence identity in 7 conserved replicase domains to SARSuses the same cell entry receptor, ACE2, as SARShttps://t.co/iwaHTsDGJN pic.twitter.com/dGEjBvGx4j— Andy Biotech (@AndyBiotech) January 23, 2020This is major progress in understanding #Parkinsons disease biology!~ #LRRK2 atomic resolution #cryoEM structure~ Switch between active / inactive conforma [...]

Jorge De Castro Font, 45, a former senator in the Commonwealth of Puerto Rico, pleaded guilty today to 20 counts of honest services wire fraud and one count of conspiracy to commit extortion.

Three air cargo carriers, LAN Cargo S.A. (LAN Cargo), Aerolinhas Brasileiras S.A. (ABSA), and EL AL Israel Airlines Ltd. (EL AL), have each agreed to plead guilty and pay criminal fines totaling $124.7 million for their roles in a conspiracy to fix prices in the air cargo industry.

A Chicago police officer pleaded guilty today to violating the federal civil rights of a man whom the officer struck repeatedly with a dangerous weapon while the man was handcuffed and shackled in a wheelchair.

Phat Ngoc Tran, 35, pleaded guilty today in San Diego to conspiring to participate in a racketeering enterprise, the “Tran Organization,” in a scheme to cheat at least 12 casinos across the United States and Canada out of millions of dollars. Tran admitted that he and his co-conspirators unlawfully obtained up to $2.5 million during card cheats.

A Ghanian man was sentenced today in the District of Columbia for his role in smuggling East Africans into the United States. Mohammed Kamel Ibrahim, a/k/a Hakim, 27, a native of Ghana and naturalized citizen of Mexico, was sentenced to five years in prison by U.S. District Judge Ricardo M. Urbina after pleading guilty to one count of conspiracy and three counts of bringing aliens to the United States for profit.

A former employee of the New York Power Authority (NYPA) was sentenced today to serve 37 months in jail and to pay a $5,000 criminal fine for his role in a kickback and bribery scheme.

Barrday Inc. and two related companies have agreed to pay the United States more than $1 million to resolve allegations that they violated the False Claims Act in connection with their role in the weaving of Zylon fabric used in the manufacture and sale of defective Zylon bullet-proof vests. Barrday, headquartered in Cambridge, Ontario, Canada, is a weaver of ballistic fabrics and designs and produces specialty industrial textiles.

Brian Carranza, 21, pleaded guilty today before U.S. District Court Judge Carol B. Amon in Brooklyn, N.Y., to conspiring to assault African-American residents in Staten Island, N.Y., in retaliation for President Barack Obama winning last year’s presidential election.

Roy Lynn Oakley, 67, a resident of Harriman, Tenn., pleaded guilty today in U.S. District Court in Knoxville, to count one of an indictment charging him with unlawful disclosure of Restricted Data under the Atomic Energy Act, in violation of 42 U.S.C., Section 2274(b).