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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 […]


Biotech, Industry

Biotech raises $1.4 million to accelerate drug delivery technology

June 8, 2021

Via: EPM Magazine

CyGenica raised the money in a seed fund investment round led by global venture capital investor SOSV. CyGenica will use the funding to accelerate the validation of its technology which is designed to enable safe, targeted and affordable intercellular drug […]


Cell and Gene Therapy, Industry

Quality considerations for a growing gene therapy field

June 7, 2021

Via: Biopharma Dive

The approvals of Roche’s Luxturna (2017) for inherited retinal disease and Novartis’ Zolgensma (2019) for spinal muscular atrophy are indicative of a resurgence in the gene therapy field after a decline due to the death of a patient in 1999. […]


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

Via: Drugs.com

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, […]


Clinical Trials, Manufacturing, Research and Development

Recro to Expand its Clinical Trial Services Offerings

June 3, 2021

Via: Biopharm International

Recro Pharma, a contract development and manufacturing organization (CDMO), announced on June 2, 2021 that it has expanded the clinical capabilities of its clinical trial services (CTS) offerings. The added capabilities include clinical-scale sachet and blister packaging for clinical trial […]


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 […]


FDA, Regulations

FDA approves Alkermes’ Lybalvi for schizophrenia and bipolar I disorder

June 2, 2021

Via: Pharma Times

Lybalvi (olanzapine and samidorphan) has been authorised as maintenance monotherapy of adults with schizophrenia or bipolar I disorder, for the acute treatment of manic or mixed episodes and as monotherapy or an adjunct to lithium or valproate. In clinical trials, […]


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 […]


Cell and Gene Therapy, Industry, Mergers and Acquisitions

Novo Nordisk partners with Heartseed on heart failure cell therapy

June 1, 2021

Via: PMLiVE

HS-001, Heartseed’s lead asset, is an investigational cell therapy using purified cardiomyocytes derived from induced pluripotent stem cells (iPSC). The therapy is currently being developed as a treatment for heart failure. Heartseed is already planning to launch a phase 1/2 […]


Clinical Trials, Research and Development

4 insights on decentralized trials for biotechs

June 1, 2021

Via: Biopharma Dive

The COVID-19 pandemic accelerated the adoption of decentralized clinical trials (DCTs) by biopharma companies. The clinician-patient relationship will always be key to clinical trials, but decentralized aspects such as direct-to-patient shipments and telehealth are here to stay. Here are four […]