Category: News

Industry, News, Vaccines

Pfizer’s COVID-19 Vaccine Protects Against SARS-CoV-2 Variants

June 14, 2021

Via: Genetic Engineering and Biotechnology News

The good news about vaccines and variants continues to roll in. Last week, a study reported that Johnson & Johnson’s COVID-19 vaccine protected against all of the SARS-CoV-2 variants of concern. Now, Pfizer’s COVID-19 vaccine has been shown to protect […]

FDA, News, Regulations

J&J must ditch 60m COVID jabs made at US plant, but 10m are okay, says FDA

June 14, 2021

Via: Pharmaphorum

The problems at the plant run by contract manufacturer Emergent BioSolutions first emerged a few weeks ago, after an FDA inspection uncovered a string of violations including that the building was “not maintained in a clean and sanitary condition.” While […]

FDA, Industry, News, Vaccines

Ocugen gets a black eye as FDA denies emergency OK for COVID jab

June 11, 2021

Via: Pharmaphorum

That will hold back the biotech’s Covaxin shot by several months, and the delay put pressure on Ocugen’s share price, which fell more than 25% after the announcement. The Philadelphia-based company said it had taken the decision to go down […]

Industry, News, Vaccines

Study links AstraZeneca COVID-19 shot to bleeding disorder ITP

June 10, 2021

Via: Pharmaphorum

The scientists examined real-world public health data from all individuals in Scotland who received either the AZ or Pfizer/BioNTech vaccines up until 14 April and found a possible association between the AZ shot and an autoimmune disorder called idiopathic thrombocytopenic […]

Mergers and Acquisitions, News

Merck signs $1.2bn supply deal with US government for Molnupiravir

June 9, 2021


The treatment, being developed by Merck in collaboration with Ridgeback Biotherapeutics, is currently being evaluated in a phase 3 clinical trial. The trial, know as the MOVe-OUT study, is evaluating molnupiravir in the treatment of non-hospitalised patients with laboratory-confirmed COVID-19 […]

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 […]

Mergers and Acquisitions, News

Biotech venture capital still booming as venBio raises another $550M

June 3, 2021

Via: Biopharma Dive

Venture capitalists interested in biotech have been able to raise money with unprecedented ease over the past several years. Polaris Partners, 5AM Ventures, Third Rock Ventures, Versant and venBio are just some of the firms to have secured hundreds of […]

Manufacturing, News, Research and Development

Moderna ramps up EU COVID jab capacity via Lonza deal

June 2, 2021

Via: Pharmaphorum

The increased capacity depends on Moderna getting approval for a half dose of an updated version of the mRNA-1273 vaccine – targeting new variants of SARS-CoV-2 – that could be used as a booster shot and for immunising children. The […]

FDA, News, Regulations

J&J, Legend Biotech’s multiple myeloma CAR-T scores FDA priority review, setting up a clash with BMS’ Abecma

May 28, 2021

Via: FiercePharma

When Bristol Myers Squibb and bluebird bio scored an FDA nod for their multiple myeloma CAR-T drug Abecma in March, industry watchers knew a competitor from Johnson & Johnson and Legend Biotech wasn’t too far behind. Now, that rival is […]

Industry, News, Vaccines

Moderna will file COVID-19 jab for teens after trial shows 100% protection

May 25, 2021

Via: Pharmaphorum

The results of the phase 2/3 TeenCOVE study in more than 3,700 adolescents aged 12 to 17 revealed no cases of COVID-19 after two doses of the mRNA-1273 shot, giving it a top-line efficacy of 100% in this age group. […]

FDA, News, Regulations

FDA approves Janssen’s Rybrevant

May 24, 2021

Via: Pharma Times

In the US, currently available targeted treatments such as EGFR tyrosine kinase inhibitors (TKIs) are not FDA-approved for treating NSCLC driven by EGFR exon 20 insertion mutations. On top of that, NSCLC driven by this particular mutation often carries a […]

Cell and Gene Therapy, Industry, News

Allogene set to disrupt CAR-T market with pivotal trial of ‘off the shelf’ therapy

May 21, 2021

Via: Pharmaphorum

Data announced ahead of this year’s American Society of Clinical Oncology (ASCO) conference suggest that Gilead and CAR-T rivals Bristol-Myers Squibb and Novartis better watch their backs as Allogene announced plans for a pivotal study this year. Allogeneic or “off […]