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Clinical Trials, Research and Development

10 clinical trials to watch in the second half of 2022

July 5, 2022

Via: Biopharma Dive

Can the biotechnology industry regain its footing after months of sliding stock values and setbacks? Recently, there have been some positive signs. Dealmaking has picked up. Drug pricing reform — a persistent concern for the industry and its investors — […]


FDA, Regulations

FDA halts tests of Sanofi drug, acquired in $3.7B buyout, due to side effects

June 30, 2022

Via: Biopharma Dive

Multiple sclerosis has a growing number of treatment options, including some newer pills that some patients prefer over older injectable or intravenous drugs that were once their only choices. Sanofi is in a race with Roche, Merck KGaA and Biogen […]


Industry, Pharma

Pharma’s post-pandemic launch performance problem: what’s the prognosis?

June 29, 2022

Via: Pharmaphorum

COVID vaccines and treatments have created a substantial market over and above the existing Rx market- IQVIA estimates that the cumulative value of COVID vaccines could be between $185 and 295bn to 2026. However, this picture of recovery hides a […]


Industry, Vaccines

US panel backs Omicron-targeting vaccines for booster campaigns

June 29, 2022

Via: Pharmaphorum

After hours of deliberation, the panellists voted by 19 to two in favour of using redesigned booster shots, rather than simply using the currently authorised vaccines – although there was broad acknowledgement that the decision comes on the back of […]


Industry, Pharma

Relay details new research plans in quest to design better cancer drugs

June 27, 2022

Via: Biopharma Dive

Relay has raised more than $1 billion on the promise that its protein motion technology can help it discover and develop better drugs in less time. Its efforts remain in early stages and, so far, don’t prove its approach can […]


Clinical Trials, Research and Development

Study exposes lack of diversity in US cancer trials

June 27, 2022

Via: Pharmaphorum

The analysis – from a dataset that spans more than half a million patients – reveals once again the lack of inclusivity in clinical research, which undermines the ability of clinical trials to generate results that reflect the real-world situation […]


News

Merck ups the stakes in pneumococcal jab face-off with Pfizer

June 22, 2022

Via: Pharmaphorum

One of these – dubbed V116 – is a cocktail of 21 Streptococcus pneumoniae serotypes designed to have the most benefit in adult populations, and it has just cleared a phase 1/2 trial as it embarks on a phase 3 […]


Industry, Pharma

US frets over pharma supply chain security

June 22, 2022

Via: Pharmaphorum

In a global economy, across a number of industries, low-margin products are often manufactured in countries where labour is cheap. The pharmaceutical industry is no different, with India and China becoming two of the leading manufacturers and exporters of generic […]


Cell and Gene Therapy, Industry

A biotech startup launches with $38M to develop a cystic fibrosis gene therapy

June 21, 2022

Via: Biopharma Dive

Vertex’s latest treatment for cystic fibrosis is a “triple combination” drug called Trikafta, which like others from Vertex boosts the activity of a protein that’s defective in people with the disease. It has quickly become a go-to treatment, entrenching Vertex’s […]


Industry, Vaccines

EMA Starts Rolling Review of Adapted COVID-19 Vaccines

June 21, 2022

Via: Biopharm International

The European Medicines Agency (EMA) has begun a rolling review of the Spikevax vaccine that has been adapted to protect against two variant strains of SARS-CoV-2, the agency announced on June 17, 2022. The review will focus on non-clinical laboratory […]


Industry, Vaccines

With CDC Approval, COVID Shots For Kids Under 5 Ready for Delivery

June 20, 2022

Via: Drugs.com

After a final sign-off on Saturday from the head of the U.S. Centers for Disease Control and Prevention, COVID-19 vaccines for children younger than 5 have finally become a reality. “This expands eligibility for vaccination to nearly 20 million additional […]


Industry, Vaccines

FDA advisors back COVID jabs for very young children

June 16, 2022

Via: Pharmaphorum

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 21 to zero in favour of both vaccines in this age group, in light of rising rates of hospitalisations and deaths that have been seen in the very young during […]


Clinical Trials, Research and Development

Another amyloid miss in Alzheimer’s as Roche’s crenezumab fails trial

June 16, 2022

Via: Pharmaphorum

The result isn’t a big surprise – Roche terminated two phase 3 trials of crenezumab in people with prodromal to mild sporadic Alzheimer’s in early 2019 after interim analyses found it would be futile to continue – but is another […]


Industry, Manufacturing, Research and Development, Vaccines

EU governments pressure manufacturers to renegotiate contracts for COVID-19 vaccines

June 15, 2022

Via: PMLiVE

When vaccines became available earlier in the COVID-19 pandemic, countries vied for supply contracts. However, as the need for vaccines begins to slow in Europe, some countries want to amend their contracts to reduce spending and to prevent receiving more […]


FDA, Regulations

FDA Approves First Pill to Treat Severe Alopecia

June 14, 2022

Via: Drugs.com

The first pill to treat adults with severe alopecia was approved by the U.S. Food and Drug Administration on Monday. Olumiant (baricitinib) is the first FDA-approved alopecia therapy that treats the entire body rather than a specific spot, the agency […]


Industry, Vaccines

FDA staff supportive of Pfizer, Moderna COVID vaccines in young children

June 13, 2022

Via: Biopharma Dive

COVID-19 vaccines have been authorized in the U.S. for a year and a half, with the FDA progressively expanding their clearances to cover broader and broader swathes of the population. Yet they are still unavailable to the youngest children, who […]


Manufacturing, Research and Development

Resilience, a well-funded manufacturing startup, joins with the Parker Institute to make cancer drugs

June 9, 2022

Via: Biopharma Dive

While recent years have seen scientists make major advances in cutting-edge treatments such as gene and cell therapies, manufacturing remains a significant hurdle. The complex, multi-step processes required are beyond the capabilities of a traditional pharmaceutical plant. That’s where Resilience […]


FDA, Regulations

FDA Advisors Back Novavax COVID Shot

June 8, 2022

Via: Drugs.com

A U.S. Food and Drug Administration vaccine advisory panel on Tuesday recommended that Novavax’s COVID-19 shots be added to the vaccine arsenal that Americans have at their disposal. Twenty-one panel members voted to approve the vaccine, while one person abstained. […]


Cell and Gene Therapy, Industry

Immatics and Editas join up to bring CRISPR to ‘gamma delta’ cell therapy

June 7, 2022

Via: Biopharma Dive

Though small in scope, Immatics and Editas’ deal adds to a flurry of recent activity involving treatments that harness gamma delta T cells, rare white blood cells with unique tumor-fighting capabilities. Unlike the T cells used in Novartis, Gilead and […]


Biotech, Industry

Yumanity’s days as an independent biotech come to a close

June 6, 2022

Via: Biopharma Dive

After nearly eight years, Yumanity’s time as an independent company appears close to an end. The biotech was established in late 2014 — the creation of Tony Coles, Susan Lindquist and Ken Rhodes, each well-known in the pharmaceutical industry for […]