Feed aggregator

Citing Variants, Eli Lilly Asks FDA To Revoke EUA for Single Antibody Therapy

Biospace news - Fri, 04/16/2021 - 02:00
The reason for the request was the monotherapy antibody therapy is less effective against the COVID-19 variants, such as have risen from the U.K., South Africa and Brazil, as well as the growing B.1.427/B.1.429 California variant.

Relay Therapeutics Snaps up ZebiAI with $85 Million Upfront Payment

Biospace news - Fri, 04/16/2021 - 02:00
In an effort to boost drug discovery for the “toughest drug discovery problems” through the use of machine learning, precision medicines company Relay Therapeutics is acquiring Waltham, Mass.-based ZebiAI with an $85 million upfront payment.

Pacira Takes ASA to Court in Defense of Non-Opioid Painkiller

Biospace news - Fri, 04/16/2021 - 02:00
With its only approved drug product on the line, Pacira Biosciences is fighting back against what it's calling “misrepresentation of the clinical effectiveness” of its non-opioid pain reliever Exparel.

Research Roundup: UK Variant Not as Lethal as Originally Reported and More

Biospace news - Fri, 04/16/2021 - 02:00
Every week there are numerous scientific studies published. Here’s a look at some of the more interesting ones.

Monkey-Human Hybrid Research Offers Promise, but Sparks Ethical Debate

Biospace news - Fri, 04/16/2021 - 02:00
According to the researchers, who published their findings online in Cell, certain experiments can't be conducted in humans, making nearly human hybrids a possible solution to this investigational barrier.

TG Therapeutics Touts Additional Positive Data, Plans Regulatory Submission for MS Drug

Biospace news - Fri, 04/16/2021 - 02:00
TG Therapeutics is on track for a regulatory submission for anti-CD20 antibody ublituximab next quarter, on the back of new Phase III data showing it reduces relapses and brain lesions in patients with relapsing forms of multiple sclerosis (MS).

BioSpace Movers & Shakers, April 16

Biospace news - Fri, 04/16/2021 - 02:00
Biopharma and life sciences companies strengthen their leadership teams and boards with these Movers & Shakers.

Abzena Plans $200 Million Manufacturing Biologics Facility in N.C.

Biospace news - Fri, 04/16/2021 - 02:00
Abzena is opening another manufacturing site, its sixth in a global network. This morning, the partner research organization announced it would build a $200 million facility in Sanford, N.C.

SARS-CoV-2: New findings on the persistence of neutralizing antibodies

World Pharma News - Thu, 04/15/2021 - 12:00
It is an open question to what extent protection against reinfection persists after overcoming a SARS-CoV-2 infection. The "Rhineland Study", a population-based study conducted by DZNE in the Bonn area, is now providing new findings in this regard. Blood samples taken last year indicate that an important component of immunity - the levels of specific neutralizing antibodies against the coronavirus - had dropped in

GSK and Vir Biotechnology announce EMA review of dual-action monoclonal antibody VIR-7831 for the early treatment of COVID-19

World Pharma News - Thu, 04/15/2021 - 10:00
GlaxoSmithKline plc and Vir Biotechnology, Inc. today announced that the European Medicines Agency (EMA) has started a review of VIR-7831 (GSK4182136), an investigational dual-action SARS-CoV-2 monoclonal antibody, for the treatment of adults and adolescents (aged 12 years and over and weighing at least 40 kg) with COVID-19 who do not require oxygen supplementation and who are at high risk of progressing to severe COVID-19.

Pfizer CEO: Third COVID-19 Vaccine Dose Will Likely Be Needed Within 12 Months

Biospace news - Thu, 04/15/2021 - 02:00
Although the data is not there, Pfizer’s chief executive officer, Albert Bourla, recently said he thought people will “likely” need a booster dose of a vaccine within 12 months of getting fully vaccinated. It’s possible, he also said, they will need to be vaccinated annually.

Thermo Fisher Drops $17.4 Billion to Buy a Popular CRO

Biospace news - Thu, 04/15/2021 - 02:00
The medical device maker has been dropping money like rain this spring, spending close to $19 billion in acquisitions over the past four months.

Merck Ditches $425 Million COVID-19 Drug, Refocusing on Another Candidate

Biospace news - Thu, 04/15/2021 - 02:00
This marks another setback for Merck in the battle against COVID-19 after it shuttered its pandemic vaccine program in January following poor responses in Phase I studies.

BioAge Makes A Big Bet on Amgen Drug To Target Muscle Aging

Biospace news - Thu, 04/15/2021 - 02:00
BGE-105 (formerly AMG 986) mimics the production of apelin, a peptide that has been found in animal studies to improve muscle regeneration and decrease mouse frailty.

Fresh Biopharmas Join the Race to Cutting-Edge Treatments and Testing

Biospace news - Thu, 04/15/2021 - 02:00
Several companies launched with Series A financing rounds today. Read on for details.

GSK Halts Two Mid-Stage Studies of ICOS Agonist Feladilimab

Biospace news - Thu, 04/15/2021 - 02:00
GlaxoSmithKline halted two mid-stage studies assessing feladilimab combined with Merck’s Keytruda as a potential treatment in different oncology settings.

Inovio’s DNA Vaccine Generates Robust Responses Against COVID-19 Variants in Study

Biospace news - Thu, 04/15/2021 - 02:00
Shares of Inovio are climbing in early trading this morning after the company announced its DNA vaccine candidate for COVID-19 induced a robust T-cell response against multiple variants of the SARS-CoV-2 virus.

COVID-19 Infection After Vaccine is Rare But Possible, CDC Says

Biospace news - Thu, 04/15/2021 - 02:00
The U.S. CDC said up to 5,800 people who have been fully vaccinated against coronavirus disease 2019 (COVID-19) have been infected by the novel coronavirus following vaccination.

Medable Raises $194 Million In a Year to Push Digital Clinical Trials

Biospace news - Thu, 04/15/2021 - 02:00
Software company Medable raised a $78 million extension on its Series C round–totaling $194 million in venture funding over three raises in the past year–to tap the growing opportunity in decentralized digital clinical trials.

Massive fragment screen points way to new SARS-CoV-2 inhibitors

World Pharma News - Wed, 04/14/2021 - 12:00
New research published in Science Advances provides a template for how to develop directly-acting antivirals with novel modes of action, that would combat COVID-19 by suppressing the SARS-CoV-2 viral infection. The study focused on the macrodomain part of the Nsp3 gene product that SARS-CoV-2 uses to suppress the host cell's natural antiviral response.