Tag: FDA

FDA, Industry, Regulations, Vaccines

Pfizer plans to file for full FDA approval of Covid vaccine at the end of this month

May 4, 2021


Pfizer said Tuesday it plans to file for full U.S. approval of its Covid-19 vaccine with German drugmaker BioNTech at the end of this month. If the FDA signs off, the company will be able to market the shot directly […]

FDA, Regulations

FDA approves expanded use for Chiesi’s sickle cell drug Ferriprox

May 4, 2021


Ferriprox (deferiprone) is now approved in the US for the treatment of transfusional iron overload due to SCD or other anaemias in adult and paediatric patients aged three years or older. The new approval expands the use of Ferriprox beyond […]

Cell and Gene Therapy, Industry, News

Gene Therapy CDMO Forges Ahead with $120M Series B Financing

April 29, 2021

Via: Genetic Engineering and Biotechnology News

Gene therapy-focused CDMO Forge Biologics has closed on a $120 million Series B financing, saying the proceeds will accelerate its planned expansion of adeno-associated virus (AAV) manufacturing capabilities. The company operates a 175,000-square-foot cGMP facility in Columbus, OH, dedicated to […]

Cell and Gene Therapy, FDA, Industry, 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 […]

FDA, Regulations

FDA cites Emergent for failings at plant that contaminated J&J doses

April 22, 2021

Via: Biopharma Dive

The FDA’s report gives the clearest picture yet of some of the manufacturing failings that led to the costly error at Emergent’s plant last month, a setback that could imperil the steady supply of J&J’s vaccine in the U.S. Inspectors […]


Hikma shares rally after US launch of Advair generic resumes

April 21, 2021

Via: Pharmaphorum

The London-listed firm is one of several companies that had been trying to make generics of GlaxoSmithKline’s former respiratory diseases blockbuster for the US market. Advair (fluticasone+salmeterol) is approved to prevent flare-ups or worsening of chronic obstructive pulmonary disease (COPD) […]

Cell and Gene Therapy, Industry, Mergers and Acquisitions

SparingVision to buy GAMUT and potential Luxturna eye gene therapy competitor

April 20, 2021

Via: Pharmaphorum

GAMUT’s lead product, now SPVN20, is a novel, mutation-agnostic gene therapy, which aims at restoring the function of dormant cone cells in the retina. If approved it would compete with Novartis’ Luxturna (voretigene neparvovec), the gene therapy from Roche/Spark Therapeutics, […]

FDA, Regulations

Bristol Myers’ Opdivo wins landmark FDA nod as first I-O therapy for front-line stomach cancer

April 19, 2021

Via: FiercePharma

The stomach cancer field is littered with immunotherapy shipwrecks, but one has now safely sailed past the regulatory finish line. Bristol Myers Squibb’s Opdivo, used in tandem with chemotherapy, won FDA approval for previously untreated gastric cancer, gastroesophageal junction cancer […]

FDA, Regulations

FDA approves immunotherapy for first-line treatment of advanced gastric cancer

April 16, 2021

Via: Medical News

Today, the U.S. Food and Drug Administration approved Opdivo (nivolumab), in combination with certain types of chemotherapy, for the initial treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma. This is the first FDA-approved […]

Industry, News, Vaccines

Merck, in latest COVID-19 setback, scraps one drug and pins hopes on another

April 15, 2021

Via: Biopharma Dive

The coronavirus pandemic has made winners out of previously unproven biotechs like Moderna and BioNTech, which each developed strongly successful vaccines in record time. But it’s also featured surprising setbacks for some of the world’s leading infectious disease companies, like […]

Industry, Vaccines

Why delivering Covid-19 vaccines is the logistics industry’s biggest challenge

April 14, 2021

Via: EPM Magazine

The sheer speed of developing and gaining regulatory approval for effective vaccines against Covid-19 has been unprecedented. Transporting them rapidly and safely from manufacturing sites to vaccination centres and doctors’ surgeries across the world is possibly the biggest challenge the […]

FDA, Industry, Regulations, Vaccines

J&J Covid-19 vaccine recommended to be put on pause in US after rare blood clots

April 13, 2021

Via: EPM Magazine

The company’s vaccine, which is manufactured by its subsidiary Janssen, has been administered to over 6.8 million people in the US. The decision by the FDA and the CDC was made after reports of six cerebral venous sinus thrombosis (CVST) […]