November 5, 2021
Via: FierceBiotechPfizer’s oral COVID-19 antiviral Paxlovid has cut the risk of hospitalization or death by 85% in a late-phase trial, prompting the Big Pharma to stop the study and race to seek emergency use authorization from the FDA. Merck showed oral […]
October 25, 2021
Via: FierceBiotechMerck has opened another front in its campaign to get molnupiravir to market, kicking off a process that could lead to the approval of the oral COVID-19 antiviral in the EU. Things have moved quickly since Merck and partner Ridgeback […]
October 4, 2021
Via: PharmaphorumMerck and partner Ridgeback Therapeutics have said they will see emergency use authorisation from the FDA for molnupiravir on the strength of the data, which suggest the drug could be used in the community to keep people from developing severe […]
October 1, 2021
Via: FierceBiotechThe wait for an oral antiviral against COVID-19 may almost be over. Friday, Merck reported its prospect halved the risk of hospitalization and death in phase 3, spurring it to stop the study and race to get emergency use authorization. […]
Clinical Trials, Industry, Pharma, Research and Development
August 30, 2021
Via: Biopharma DiveAbrocitinib is one of Pfizer’s top experimental therapies, pegged by the drugmaker for several billion dollars in peak annual sales in the future. But its fate, along with the fate of two other drugs from AbbVie and Lilly that are […]
August 6, 2021
Via: Kaiser Health NewsThe clock was about to strike midnight, and Scott Newman was desperately feeding pages into a scanner, trying to prevent thousands of dollars in prescription payments from turning into a pumpkin. As the owner of Newman Family Pharmacy, an independent […]
July 22, 2021
Via: FiercePharmaPfizer and its JAK inhibitors are falling deeper down a regulatory rabbit hole the company itself opened up. The FDA has once again pushed back two decisions key to Pfizer’s immunology franchise: Xeljanz in ankylosing spondylitis and abrocitinib in atopic […]
Cell and Gene Therapy, Industry, News, Pharma
June 7, 2021
Via: Pharma TimesThis includes the company’s lead pre-clinical ADC candidate IKS03, a potentially ‘best-in-class’ CD19-targeted asset for B-cell cancers. Iksuda will use the funds to support the progression of IKS03 into first-in-human Phase I clinical trials, and will also be used to […]
June 4, 2021
Via: FiercePharmaMost people don’t normally think about the intricacies of the pharma supply chain, but the COVID-19 pandemic suddenly pushed the topic front and center. Now a new ad campaign from the Healthcare Distribution Alliance celebrates the critical work of healthcare […]
FDA, Industry, Pharma, Regulations
May 28, 2021
Via: PMLiVEThe FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted 10-7 in favour of the benefits of teplizumab outweighing its risks to support approval of the drug to delay type 1 diabetes. The EMDAC based its recommendation on data from […]
Cell and Gene Therapy, FDA, Industry, Pharma, Regulations
April 23, 2021
Via: EPM MagazineShorla Pharma’s SH-111 treatment is being designed as an alternative therapy for T-cell acute lymphoblastic leukaemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL). It will be targeted at paediatric patients over the age of one whose disease has not responded or […]
March 5, 2021
Via: Biopharma DiveMerck, under outgoing CEO Ken Frazier and now retired research chief Roger Perlmutter, has stayed away from large-scale dealmaking. But the pharma has proven an enthusiastic acquirer of early-stage, smaller companies, buying up seven private and public biotechs over the […]
February 25, 2021
Via: BioSpaceLyophilization has been popularly employed by the pharmaceuticals industry in parenteral product development. The process has the potential to improve the shelf-life, increase the efficacy of formulations, especially complex injectables, and to make them easier to store and transport. Biopharmaceutical […]
December 24, 2020
Via: BioSpaceAlgernon Pharmaceuticals Inc. (CSE: AGN) (FRANKFURT: AGW) (OTCQB: AGNPF) (the “Company” or “Algernon”) a clinical stage pharmaceutical development company announces that the Company has elected to exercise its acceleration right under the warrant indenture (the “Indenture”) governing the common share […]
September 15, 2020
Via: BioSpaceTimber Pharmaceuticals, Inc. (“Timber” or the “Company”) (NYSE American: TMBR), a biopharmaceutical company focused on the development and commercialization of treatments for orphan dermatologic diseases, today announced that it has received a formal notice of allowance from the U.S. Patent […]
September 1, 2020
Via: Genetic Engineering and Biotechnology NewsExperimental drugs face steep odds. According to the Pharmaceutical Research and Manufacturers of America (PhRMA), out of every 5,000 to 10,000 compounds that enter the discovery and development pipeline, just 5 enter clinical trials, and only 1 receives approval. Other […]
August 12, 2020
Via: BioSpacePhio Pharmaceuticals Corp. (Nasdaq: PHIO), a biotechnology company developing the next generation of immuno-oncology therapeutics based on its proprietary self-delivering RNAi (INTASYL™) therapeutic platform, today reported its financial results for the quarter ended June 30, 2020 and provided a business […]
Clinical Trials, Industry, Pharma, Research and Development
August 7, 2020
Via: Pharma IQAs the pharma industry stands firm in its commitment to advance the sector to fight Covid-19, news has emerged from the European Commission who intend to streamline the development of therapies using genetically modified organisms to treat Covid-19. The governing […]
July 17, 2020
Via: FierceBiotechThe FDA has granted priority review status to Merck’s vericiguat, teeing the Big Pharma to receive an approval decision early next year. Vericiguat, which Merck partnered on with Bayer in a $1 billion deal, will enter the increasingly congested heart […]
FDA, Industry, Pharma, Regulations
July 15, 2020
Via: Biopharma DiveThe BCMA protein has emerged as a target of interest in multiple myeloma because it is expressed on malignant cells but not on normal tissue. As a result, drugmakers have developed several different approaches to home in on BCMA-expressing cells, […]