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Category: Pharma


Industry, Pharma

UPDATE: Pfizer’s oral COVID-19 antiviral cuts hospitalization, death by 85%, sending team barreling to FDA

November 5, 2021

Via: FierceBiotech

Pfizer’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 […]


Industry, Pharma

EMA starts rolling review of Merck’s molnupiravir, continuing rapid regulatory response to COVID-19 antiviral data

October 25, 2021

Via: FierceBiotech

Merck 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 […]


Industry, Pharma

Merck preps filings for oral COVID drug, but is it really a game changer?

October 4, 2021

Via: Pharmaphorum

Merck 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 […]


Industry, Pharma

Merck’s oral COVID-19 antiviral slashes hospitalizations, prevents deaths in phase 3, sparking race to file with FDA

October 1, 2021

Via: FierceBiotech

The 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

Pfizer drug bests Sanofi, Regeneron’s Dupixent in head-to-head study

August 30, 2021

Via: Biopharma Dive

Abrocitinib 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 […]


Industry, Pharma

Pharmacies Face Extra Audit Burdens That Threaten Their Existence

August 6, 2021

Via: Kaiser Health News

The 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 […]


Industry, Pharma

Pfizer’s immunology ambitions delayed—again—as JAK drugs fall victim to FDA’s protracted safety review

July 22, 2021

Via: FiercePharma

Pfizer 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

Iksuda Therapeutics raises $47m to progress ADC pipeline

June 7, 2021

Via: Pharma Times

This 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 […]


Industry, Pharma

Pharma delivers: New campaign celebrates pharma distribution companies’ role during pandemic

June 4, 2021

Via: FiercePharma

Most 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

FDA panel backs Provention Bio’s type 1 prevention drug teplizumab

May 28, 2021

Via: PMLiVE

The 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

FDA accepts filing for Shorla Pharma’s leukaemia treatment

April 23, 2021

Via: EPM Magazine

Shorla 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 […]


Industry, News, Pharma

Biotech’s deal refusals led to pricey buyout by Merck

March 5, 2021

Via: Biopharma Dive

Merck, 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 […]


Industry, Pharma

Lyophilization Services for Biopharmaceuticals Market Review Report with Future Aspect Analysis

February 25, 2021

Via: BioSpace

Lyophilization 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 […]


Industry, Pharma

Algernon Pharmaceuticals Announces Acceleration of Expiry Date of Warrants

December 24, 2020

Via: BioSpace

Algernon 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 […]


Industry, News, Pharma

Timber Pharmaceuticals Receives Notice of Allowance from U.S. Patent and Trademark Office for BPX-01 and BPX-04

September 15, 2020

Via: BioSpace

Timber 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 […]


Industry, Pharma

Drug Targets Identified More Discerningly

September 1, 2020

Via: Genetic Engineering and Biotechnology News

Experimental 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 […]


Industry, Pharma

Phio Pharmaceuticals Reports Second Quarter 2020 Financial Results and Provides Business Update

August 12, 2020

Via: BioSpace

Phio 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

Keeping tabs on Covid-19: Cell and gene clinical trials advance despite Covid-19…

August 7, 2020

Via: Pharma IQ

As 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 […]


Industry, Pharma

FDA puts Merck’s heart failure drug on priority review track

July 17, 2020

Via: FierceBiotech

The 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

Side effects don’t stop FDA panel from backing GSK blood cancer drug

July 15, 2020

Via: Biopharma Dive

The 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, […]