Tag: drug manufacturing

Industry, Vaccines

NCCN experts provide new guidance on COVID-19 vaccines for cancer patients

June 11, 2021

Via: Medical News

The National Comprehensive Cancer Network (NCCN) today announced the publication of new guidance on COVID-19 vaccines for people with cancer, intended to clear up confusion for patients and caregivers. The new four-page patient guide is based on the latest expert […]

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 […]

Manufacturing, Research and Development

After COVID-19 spotlighted supply chain weaknesses, Biden unveils plan to resurrect U.S. drug manufacturing

June 8, 2021

Via: FiercePharma

After investigating America’s supply chains, including those for drugs and pharmaceutical ingredients, the Biden administration has revelations to share—and it’s proposing a sweeping strategy to boost domestic drug production. Under the plan, the White House is establishing a public-private partnership […]

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 […]

Industry, Vaccines

White House Lists Countries Getting First Batch of Extra COVID Vaccines

June 4, 2021


An initial 25 million doses of coronavirus vaccines will be sent out this month to a “wide range of countries” in Latin America, the Caribbean, Southeast Asia and Africa, along with the Palestinian territories, war-ravaged Gaza and the West Bank, […]

Manufacturing, Research and Development

Biogen’s $1B Swiss plant scores regulatory nod as drugmaker awaits pivotal FDA decision on aducanumab

May 25, 2021

Via: FiercePharma

Despite a flurry of uncertainty surrounding Biogen’s Alzheimer’s hopeful aducanumab, the company has forged ahead with its launch preparations ahead of a pending FDA decision. Now, its Swiss manufacturing facility is a step closer to eventually churning out doses—should the […]

Clinical Trials, Research and Development

Exscientia starts trials of AI-designed Alzheimer’s drug

May 13, 2021

Via: Pharmaphorum

The new molecule – called DSP-0038 – is being developed by Japan’s Sumitomo Dainippon Pharma (DSP), which is now starting a phase 1 trial in the US as a treatment for psychosis associated with Alzheimer’s, and to see if it […]

Industry, Vaccines

Moderna announces additional investments to increase global supply for COVID-19 vaccine to up to 3 billion doses in 2022

April 29, 2021

Via: World Pharma News

Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced it is making new funding commitments to increase supply at its owned and partnered manufacturing facilities, which it expects will increase global 2022 capacity […]

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 […]

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 […]

Biotech, FDA, Industry, Regulations

Airway Therapeutics Announces FDA Acceptance of IND for AT-100’s Second Indication in Severe COVID-19 Patients

April 12, 2021

Via: BioSpace

Airway Therapeutics, Inc., a biopharmaceutical company developing a new class of biologics to break the cycle of injury and inflammation for patients with respiratory and inflammatory diseases, today announced the U.S. Food and Drug Administration (FDA) has accepted its Investigational […]