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WHO lists additional COVID-19 vaccine for emergency use and issues interim policy recommendations

World Pharma News - Fri, 05/07/2021 - 10:00
WHO today listed the Sinopharm COVID-19 vaccine for emergency use, giving the green light for this vaccine to be rolled out globally. The Sinopharm vaccine is produced by Beijing Bio-Institute of Biological Products Co Ltd, subsidiary of China National Biotec Group (CNBG).

Pfizer/BioNTech and Moderna Seek Full FDA Approval for COVID-19 Vaccines

Biospace news - Fri, 05/07/2021 - 02:00
Six months after receiving Emergency Use Authorization from the U.S. FDA for COVID-19 vaccines, Pfizer/BioNTech and Moderna are planning to seek full approval for the preventative medications.

IPO and SPAC Boom Continues as More Life Sciences Companies Announce Terms

Biospace news - Fri, 05/07/2021 - 02:00
With 2020 holding a record number of biotech IPOs, this year is lining up to come close. Three more Bay Area life science companies are just about ready to hit the Nasdaq, adding to the growing list for 2021.

Disappointing Study Results Force Galapagos NV to Refocus Pipeline, Adjust Operations

Biospace news - Fri, 05/07/2021 - 02:00
Galapagos NV will refocus its clinical pipeline and make some cost adjustments to save the company €150 million after disappointing studies assessing therapies for rheumatoid arthritis and idiopathic pulmonary fibrosis.

Pharma Industry Leaders: COVID-19 Vaccine IP Waiver Concept Flawed

Biospace news - Fri, 05/07/2021 - 02:00
On Thursday, Pfizer Chief Executive Officer Albert Bourla who is “not at all” in favor of the U.S. position, stated that the real challenge is manufacturing capacity.

FDA Adcom Almost Evenly Split Vote on ChemoCentryx’s Vasculitis Drug

Biospace news - Fri, 05/07/2021 - 02:00
The FDA released a briefing document that expressed concerns over ChemoCentryx’s avacopan. Company shares plummeted 46.5% at the news.

Nkarta and CRISPR Therapeutics Join Forces to Develop Natural Killer Cell Cancer Treatments

Biospace news - Fri, 05/07/2021 - 02:00
Biopharmaceutical company CRISPR Therapeutics has entered into a strategic research, development and commercialization partnership with cancer-focused Nkarta.

AstraZeneca’s Tremelimumab Offers Survival Benefit With IMFINZI in Advanced Lung Cancer

Biospace news - Fri, 05/07/2021 - 02:00
A final analysis of AstraZeneca’s Phase III POSEIDON trial shows IMFINZI (durvalumab), offered improvements in overall survival (OS) when added to tremelimumab and chemotherapy versus chemotherapy alone in patients with Stage IV (metastatic) non-small cell lung cancer.

COVID-19 in the News: Heart Inflammation, Vaccine Effectiveness and More

Biospace news - Fri, 05/07/2021 - 02:00
There’s a fair amount of new information coming out about COVID-19 and vaccines. Here’s a roundup of some of the top stories.

Research Roundup: Genetics of People Older than 105 and More

Biospace news - Fri, 05/07/2021 - 02:00
Every week there are numerous scientific studies published. Here’s a look at some of the more interesting ones.

Athira Pharma is Living Legacy to Founder’s Legendary Mother

Biospace news - Fri, 05/07/2021 - 02:00
Leen Kawas, president and CEO of Athira Pharma, comes from a long line of successful, trailblazing women who place an emphasis on inspiring the next generation, and she is driven to defeat neurodegenerative disease, which has stolen two of those women from her.

BioSpace Movers & Shakers, May 7

Biospace news - Fri, 05/07/2021 - 02:00
Biopharma and life sciences companies strengthen their leadership teams and boards with these Movers & Shakers.

Pfizer and BioNTech to provide COVID-19 caccine doses for olympic athletes at the 2020 Tokyo Games

World Pharma News - Thu, 05/06/2021 - 10:00
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the signing of a Memorandum of Understanding (MoU) with the International Olympic Committee (IOC) to donate doses of the companies' COVID-19 Vaccine to help vaccinate athletes, and their delegations, participating in the Olympic and Paralympic Games Tokyo 2020, which are scheduled to begin on July 23, 2021.

Biden Administration Makes Official Call on COVID-19 Vaccine IP Waiver

Biospace news - Thu, 05/06/2021 - 02:00
While the U.S. had been one of a few rich nations holding out – along with Canada, the European Union and Britain – on some level, Wednesday’s announcement of support for the proposal is not unexpected.

Merck's Blockbuster Cancer Antibody Racks Up Another Approval

Biospace news - Thu, 05/06/2021 - 02:00
The U.S. FDA approved Keytruda combined with Genentech’s Herceptin (trastuzumab), fluoropyrimidine- and platinum-containing chemotherapy, for first-line treatment of locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma.

Rocky Road for Biogen's Aducanumab Now Includes Pricing Hurdle

Biospace news - Thu, 05/06/2021 - 02:00
With Biogen’s potential treatment for Alzheimer’s, aducanumab, coming in weeks before a U.S. FDA decision, ICER wrote a punishing report slamming the drug for insufficient efficacy and recommending a low price point if approved.

With Approvals in Hand, These Three New Drugs Are Hitting the Market

Biospace news - Thu, 05/06/2021 - 02:00
Less than two weeks after receiving the greenlight for Zynlonta under accelerated approval, ADC Therapeutics has launched its treatment for adult patients with relapsed or refractory diffuse large B-cell lymphoma.

Current COVID-19 Vaccines Proving Efficacy Against New Variants

Biospace news - Thu, 05/06/2021 - 02:00
Newly-published studies suggest currently authorized COVID-19 vaccines may be effective for protecting against new and emerging variants of the novel coronavirus, while booster doses of these vaccines may improve the overall efficiencies of these immunizations at combating these variants.

Bluebird Bio Q1 Highlights: Abecma Launch, Clinical Holds, Spinout Name and More

Biospace news - Thu, 05/06/2021 - 02:00
Bluebird bio reported first-quarter earnings, the approval of Abecma, the first CAR-T therapy for relapsed or refractory multiple myeloma, and its spinout, 2seventy bio, and its leadership.

Global Roundup: GENFIT Launches NASH Diagnostic Kit in US, Canada and More

Biospace news - Thu, 05/06/2021 - 02:00
Biopharma and life sciences companies from across the globe provide updates on their businesses and pipelines.