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.
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.
Global drugmakers are working overtime to keep supplies coming amid the novel coronavirus pandemic. But in manufacturing facilities packed with workers, COVID-19 presents a particularly difficult challenge—and now one Indian plant has been forced to shutter due to a rash of infections.
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.
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.
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.
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.
The world is waiting for Gilead Sciences to set a price tag for remdesivir, the first brand-new med authorized to treat COVID-19. Its choice will affect Gilead's reputation and bottom line, set a tone for follow-up meds—and either help polish up the pharma industry's image or create a new flashpoint for criticism.
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.
Global coronavirus vaccine makers have been rolling out details about their manufacturing and launch plans—even ahead of any clinical data. Now, Pfizer says it will draw on three sites in the U.S., plus one in Belgium, for the early stages of a launch, provided its BioNTech-partnered shot wins a green light.
Amgen is planning to file for FDA approval of Otezla in mild to moderate plaque psoriasis based on new data showing patients on the drug experienced significant improvements in their symptoms. The label expansion will be key to Amgen's ability to recoup the $13.4 billion it paid to acquire the drug from Celgene last year.
German drugmaker Fresenius Kabi has made major investments in its U.S. manufacturing operations in recent years with some mixed quality results along the way. Now, one of the drugmaker's products faces a recall for more manufacturing woes.
AstraZeneca has watched superstar SGLT2 diabetes med Farxiga nail trial after trial in highly coveted kidney and heart failure indications, with the FDA expediting reviews to back them up. The one thing AstraZeneca was missing? The agency taking Farxiga across the finish line.
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.
AbbVie and Allergan have waited for nearly a year for their much-discussed merger to pass muster. Finally, after pushback from consumer groups and tight scrutiny from regulators, the FTC has granted its green light. The partners face just one final hurdle to consummating their deal.
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.
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.
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.
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.
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.
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.
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.
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.
US biotech firm jCyte Inc has entered into a licensing agreement with Japanese ophthalmology specialist…
US pharma major AbbVie has finally completed its $63 billion acquisition of Ireland-incorporated Allergan,…
The US Food and Drug Administration has granted accelerated approval for Retevmo (selpercatinib) capsules…
Italian drugmaker Recordati has reported consolidated revenues for the first quarter of 2020 are 429.2…
As had been widely expected, Gilead Sciences on Thursday announced that the Japanese Ministry of Health,…
Canada-based BetterLife Pharma, previously known as Pivot Pharmaceuticals, has entered into an agreement…
US pharma major Bristol-Myers Squibb saw its revenue reach $10.8 billion in the first quarter of 2020,…
Israel-based Teva Pharmaceutical Industries today reported results for the quarter ended March 31, 2020,…
Shares of Dr Reddy’s Laboratories rose more than 2% to 3,936.35 rupees, after the Indian drugmaker…
COVID-19 is having varying effects on different markets within healthcare, with drug delivery systems…
Tokyo’s Daiichi Sankyo has submitted a supplemental New Drug Application (sNDA) for trastuzumab deruxtecan…
Privately-held Italian pharma group Mediolanum Farmaceutici has acquired the French immuno-oncology specialist…
In another strategic M&A deal announced so far this month, PTC Therapeutics has entered into an agreement…
Late Wednesday, the US Food and Drug Administration said it has granted accelerated approved for Tabrecta…
GlaxoSmithKline has completed divestment of its Horlicks and other Consumer Healthcare nutrition products…
A multi-year collaboration between China’s Innovent Biologics and USA-based Eli Lilly is bearing fruit,…
The fallout from the COVID-19 pandemic has been challenging for many life sciences companies due to a…
Mark Brewer, who heads up the life sciences team at UK broker and M&A advisory company, finnCap, gives…
Positive Phase III data for Recarbrio (imipenem/cilastatin/relebactam) have been announced by New Jersey,…
Canada-based Bausch Health Companies, along with its wholly-owned subsidiary, Salix Pharmaceuticals and…
Eye health specialist Bausch + Lomb, part Bausch Health Companies, has entered into an exclusive licensing…
Amgen’s Otezla (apremilast), a drug divested by Celgene ahead of its acquisition by Bristol-Myers Squibb,…
Germany’s science and technology company Merck KGaA today announced its investment in SynSense (formerly…
The submission of additional information, upon the request of the US regulator, has delayed the action…
US drugmaker Alexion Pharmaceuticals fared better in its revenue and adjusted earnings figures in the…
Pandemic-based stockpiling among people with diabetes helped lift revenues beyond analysts’ expectations…
Farxiga (dapagliflozin) has been approved in the US to reduce the risk of cardiovascular (CV) death and…