Pharma: Page 60
-
Eye drug side effects are real, Novartis confirms in new warning
A recent review by the Swiss pharma found Beovu caused potentially serious side effects about once in every 1,000 injections.
By Jonathan Gardner • April 9, 2020 -
Amid a pandemic, Roche bets $190M on Arrakis and drugging RNA
The deal is one of the largest for a group of companies that aim to use small molecule drugs to block the function of RNA in the body's cells.
By Ben Fidler • April 8, 2020 -
Explore the Trendline➔
Brian Tucker / BioPharma Dive/BioPharma Dive
TrendlineTop 5 stories from BioPharma Dive
Looming patent expiries this decade and intensifying competition from China are forcing drugmakers to adapt, while new opportunities open up in oncology and in neuroscience.
By BioPharma Dive staff -
FDA delays decision on Roche spinal muscular atrophy drug
Roche says the three-month delay is needed for the FDA to review new data for risdiplam, which could become the first oral option for the disabling and often fatal disorder.
By Jonathan Gardner • April 7, 2020 -
FDA's new Keytruda review is a step for genetic medicine, immunotherapy
A decision on approval, expected by June 16, would be the fourth tissue-agnostic drug approval — and could help to validate an emerging immunotherapy biomarker.
By Ben Fidler • April 7, 2020 -
National Institute of Allergy and Infectious Disease. (2020). "Novel Coronavirus SARS-CoV-2" [Image]. Retrieved from Flickr.
Takeda, CSL forge coronavirus alliance, forgoing their own drugs in the process
The companies aim to develop a blood plasma therapy for COVID-19, a task made easier by pooling resources and manufacturing facilities.
By Jacob Bell • April 7, 2020 -
GSK bets $250M on Vir's antibody approach to treating coronavirus
The companies aim to advance two antibodies developed by Vir directly into Phase 2 testing within the next three to five months, pending regulatory OK.
By Jonathan Gardner • April 6, 2020 -
Fate inks $100M J&J pact for 'off-the-shelf' cancer cell therapies
Several companies, including Fate, could soon provide meaningful data in support of allogeneic cell therapy, unless COVID-19 disrupts those plans.
By Ben Fidler • April 3, 2020 -
Novartis gives up on planned $1B generic drug sale to Aurobindo
The companies called off the deal, which was supposed to close last quarter, after failing to secure regulatory sign-off from the FTC.
By Kristin Jensen • April 2, 2020 -
Contamination concerns spur FDA call for nationwide withdrawal of heartburn drug
Some pharmacies and manufacturers had already discontinued distribution of Zantac due to impurities involving a probable human carcinogen.
By Jonathan Gardner • April 1, 2020 -
Master Sgt. Hecht, Matt. (2020). [Photograph]. Retrieved from Flickr.
Under pressure, FDA touts speedy coronavirus drug development
By redeploying staff and request "triaging," the agency says it has streamlined its process for approving use of experimental drugs for COVID-19.
By Jonathan Gardner • April 1, 2020 -
Drugmakers await reckoning as doctors, patients make tough choices during pandemic
Decisions to delay medical visits and treatment could have a ripple effect on the businesses of biotech and pharma companies.
By Ben Fidler , Jonathan Gardner • April 1, 2020 -
With latest FDA submission, Bristol Myers keeps pace with Celgene milestones
Bristol Myers' second cancer cell therapy is now on track to be approved before the deadline set in its $74 billion acquisition of Celgene last year.
By Jonathan Gardner • March 31, 2020 -
Merck's search for growth outside Keytruda may not end in heart disease
A study of vericiguat, which Merck is developing with Bayer, found the drug kept patients with declining heart function out of the hospital, but couldn't delay death.
By Jonathan Gardner • March 30, 2020 -
National Institute of Allergy and Infectious Disease. (2020). "Novel Coronavirus SARS-CoV-2" [Image]. Retrieved from Flickr.
J&J picks top coronavirus vaccine candidate; human tests to start in September
Together with BARDA, the pharma has agreed to spend $1 billion co-funding vaccine research, development and testing.
By Jacob Bell • March 30, 2020 -
Sanofi adds mRNA to coronavirus vaccine push
A deal with Translate Bio to develop an mRNA-based vaccine adds the newer technology to the French pharma’s pandemic response.
By Jonathan Gardner • March 27, 2020 -
Bristol Myers investors breathe easier as multiple sclerosis drug approved by FDA
Regulatory clearance for Zeposia is the first of three drug approval milestones that must be met for former Celgene shareholders to see the full value of the 2019 acquisition.
By Jonathan Gardner • March 26, 2020 -
In rare move, Gilead gives up 'orphan' status for experimental coronavirus drug
After sparking controversy, the biotech asked the FDA to rescind a designation designed to encourage research into therapies for rare diseases.
By Jonathan Gardner • March 25, 2020 -
AstraZeneca turns again to UK's Silence in renewed RNAi push
AstraZeneca and Silence Therapeutics, which first partnered in 2007, will team up to develop RNA interference drug candidates for diseases of the liver, heart, kidney and lung.
By Ned Pagliarulo • Updated March 25, 2020 -
Shutterstock: LightField Studios
Sponsored by ZSCOVID-19 and pharma's in-person sales model
Once the pharma industry and its customers learn to function in a world without face-to-face detailing, we may see the digital flip switch with physicians preferring to engage via digital channels.
By Pratap Khedkar Co-author: Daniel Brox • March 24, 2020 -
Permission granted by Roche
Leukemia drug from Roche, AbbVie extends survival, study finds
Paired with chemotherapy, Venclexta succeeded in a Phase 3 acute myeloid leukemia trial just weeks after falling short in another combination study.
By Jonathan Gardner • March 23, 2020 -
Courtesy of Eli Lilly
Lilly, Galapagos halt trials as coronavirus deepens impact on drug research
The moves likely herald similar announcements by other large drugmakers as medical centers focus resources on treating patients with COVID-19.
By Ben Fidler • Updated March 23, 2020 -
Permission granted by Stein IAS
Sponsored by CovanceAddressing the challenges of data management for pharmaceutical and biotechnology companies
The need for timely availability of clean data based on unique sponsor format/industry requirements has become extremely complex.
March 18, 2020 -
CDC/Alissa Eckert, MS. "covid-19 coronavirus on black background". Retrieved from https://www.cdc.gov/media/subtopic/images.htm.
No White House offer for coronavirus vaccine access, CureVac says
An abrupt exit by CEO Daniel Menichella following a meeting with President Donald Trump, and the medical leave taken this week by his successor, were "pure coincidence," a board member said.
By Jonathan Gardner • March 17, 2020 -
Pharma salesforces brought to a halt as coronavirus shutters economy
Coronavirus' spread, and the measures taken by states and cities to contain it, are forcing drugmakers like Amarin, Pfizer and Merck & Co. to pull back their sales teams from hospitals and doctors' offices.
By Ned Pagliarulo • March 17, 2020 -
Permission granted by University of Pennsylvania
Deep DiveBig pharma shied away from gene therapy for years. Academia picked up the slack
The byproduct was richer licensing fees for universities and a throng of startups, but also questions on fair prices and research priorities.
By Jonathan Gardner • March 17, 2020
Previous
