Pharmaceutical Processing World Archives - Page 36 of 64

CDC’s ACIP deprioritizes Johnson & Johnson’s COVID-19 vaccine

CDC’s Advisory Committee on Immunization Practices (ACIP) voted 15 to 0 to prioritize the Pfizer-BioNTech and Moderna COVID-19 vaccines over Johnson & Johnson’s.

One of the main reasons for the recommendation is a rare side effect associated with the Johnson & Johnson vaccine that results in low blood clots and blood-platelet levels.

CDC officials revealed that there had been 54 cases of the condition, known as thrombosis with thrombocytopenia syndrome.

FDA temporarily paused the use of the vaccine in April over blood clot concerns.

The J&J vaccine has lagged behind the mRNA-based Pfizer-BioNTech and Moderna vaccines in terms of demand.

To date, U.S. health workers have administered 17 million doses of the Johnson & Johnson vaccine compared to 286 million Pfizer-BioNTech doses and 187 million Moderna doses, according to CDC data.

The J&J vaccine also trails its rivals in terms of vaccine efficacy.

That said…

Pharma and biotech companies set their sites on sustainability

Image courtesy of Wikimedia Commons

Sustainability continues to be a hot topic, and the pharmaceutical industry faces pressure to reduce its carbon footprint. As a result, a growing number of pharma companies are stepping up sustainability efforts.

In a growing number of locations, pharma companies are seeing drivers in the regulatory environment to force them to prioritize sustainability. “We’re seeing [pressure] from both regulatory authorities having jurisdiction at the federal, state and local level of different jurisdictions,” said Jeff Wegner, a mechanical engineer at CRB.

A growing number of jurisdictions on the East Coast and West Coast are restricting or banning the use of, for instance, natural gas.

While such restrictions are not yet pervasive, the trend is building, said Wegner, who was among the authors of the Horizons: Life Sciences Report.

Another dimensi…

A future beyond distance: How remote collaboration technologies are changing how we work

Image courtesy of Avatour

Site meetings are an integral part of business for life sciences companies — whether supplier audits, internal quality assurance inspections, process reviews, or FDA inspections. Often, these site visits involve traveling long distances to bring auditors, experts, or global teams together. Pre-COVID, the pharmaceutical and biotechnology industries spent enormous budgets on travel costs.

Direct expenses aren’t the only cost of these meetings. Those who travel for site visits incur a significant overhead of productive time lost in airports and hotels. On-site safety, security and cleanliness protocols are time-consuming and disruptive, often requiring the interruption of production for days at a time. And every outside individual brought into a lab or production facility creates some amount of risk.

Until now, life sciences companies have accepted these costs because there were…

A future beyond distance: How remote collaboration technologies are changing how we work

Image courtesy of Avatour

Site meetings are an integral part of business for life sciences companies — whether supplier audits, internal quality assurance inspections, process reviews, or FDA inspections. Often, these site visits involve traveling long distances to bring auditors, experts, or global teams together. Pre-COVID, the pharmaceutical and biotechnology industries spent enormous budgets on travel costs.

Direct expenses aren’t the only cost of these meetings. Those who travel for site visits incur a significant overhead of productive time lost in airports and hotels. On-site safety, security and cleanliness protocols are time-consuming and disruptive, often requiring the interruption of production for days at a time. And every outside individual brought into a lab or production facility creates some amount of risk.

Until now, life sciences companies have accepted these costs because there were…

Pfizer plans to buy Arena Pharmaceuticals for $6.7 billion

Pfizer (NYSE:PFE) plans to spend almost $7 billion to acquire Arena Pharmaceuticals (NSDQ:ARNA) to bolster its pipeline of immuno-inflammatory drugs.

ARNA shares surged 80% to $90.08 after the announcement. PFE shares ticked up to $55.20 to 4.57%.

The transaction was valued at $100 per Arena share in cash.

The proposal has won the unanimous approval of the boards of directors at both firms.

Arena’s lead candidate etrasimod, an oral selective sphingosine 1-phosphate (S1P) receptor modulator, offers promise for several immuno-inflammatory diseases, including Crohn’s disease, atopic dermatitis and ulcerative colitis. Arena also has ongoing Phase 2 trials involving etrasimod in eosinophilic esophagitis and alopecia areata.

Earlier this year, Bristol Myers Squibb won the first gastrointestinal indication of an S1P receptor modulator. Known as ozanimod, the drug was branded as Zeopsia.

Etrasimod has been the subject of 27 clinical stu…

UK ramps up booster program to confront surge in COVID-19 cases

Boris Johnson

U.K. Prime Minister Boris Johnson has announced that the country will accelerate its coronavirus vaccination booster initiative to fight a “tidal wave” of cases resulting from the infectious Omicron variant.

Johnson acknowledged that two doses of vaccine were unlikely sufficient to fight off the recent surge in infections, which hit the second-highest level in the UK since the pandemic began.

In an interview with Sky News, Johnson reported that at least one individual infected with the Omicron variant had died. In the UK, roughly 10 people with the variant have been hospitalized to date.

To date, the country has confirmed 4,713 cases of the Omicron variant, according to Health Secretary Sajid Javid.

Javid reported that the Omicron variant is now responsible for about one in five cases in the UK.

The country will offer fully vaccinated individuals a third dose by the …

Fareva, ApiJect ink 10-year licensing agreement on fill-finish production lines

Fareva and ApiJect Systems today announced a licensing agreement to fill-finish more than 500 million injectable drug doses per year.

Under the agreement, Fareva intends to invest more than $56.5 million to install three blow-fill-seal production lines with support from the Government of France through the France Relance industry initiative, as well as the Investments for the Future Program (PIA).

Get the full story at our sister site, Drug Delivery Business News.

Why global vaccine equity could prolong the COVID-19 pandemic

[Photo by Fusion Medical Animation on Unsplash]

In May, the World Health Assembly set the goal of fully vaccinating 10% of each country’s population by September 30. A number of countries hit the goal, including 15 in Africa, but more than 50 didn’t.

“It’s very concerning,” said Donna Patterson, a fellow at the Wilson Center, in a recent webinar from that organization. Uneven vaccination rates threaten to extend the COVID-19 pandemic’s timelines. Some countries remain far behind the 10% goal. For example, the percentage of fully vaccinated people in Senegal is 5.6%. Burundi’s rate is near 0%. “There are other countries that are higher, mostly in North Africa, including Morocco, but that also varies,” said Patterson, who is also a professor at Delaware State University.

Vaccination rates are also lagging in regions such as the Caribbean, Latin Americ…

Roche finalizes repurchase of shares from Novartis

Roche (SIX:RO,ROG) has announced that it has completed the repurchase of 53.3 million shares held by Novartis (NYSE:NVS) for a total consideration of $20.7 billion.

In early November, the companies had announced that they had agreed to a bilateral transaction related to the sale of the shares.

Roche intends on canceling the repurchased shares after the transaction is complete.

“With this transaction, we regain full strategic flexibility without compromising our operational scope of action,” said Christoph Franz, Roche chairman of the board of directors.

Roche had previously stated that the transaction would not affect its communicated outlook for 2021.

In related news, Novartis CEO Vas Narasimhan said the company plans on developing an oral therapy that would target an array of coronaviruses.

FDA authorizes COVID-19 antibody cocktail for younger children

The FDA will allow the use of Lilly’s (NYSE:LLY) bamlanivimab and etesevimab antibodies for younger pediatric patients, including newborns.

The revised expanded emergency use authorization (EUA) specifically includes children with mild-to-moderate COVID-19 who face a high risk of disease progression.

The EUA previously covered children at least 12 years of age who weigh at least 40 kilograms.

Get the full story from our sister site, Drug Discovery & Development.

Fujifilm to expand vaccine production plant in England

Fujifilm (TSE:4901) has reportedly spent big to double the size of its United Kingdom-based vaccine manufacturing facility.

The Financial Times reported that Fujifilm is spending about $532.8 million (£400 million) to expand its Teesside (north-east England) plant that is making the Novavax COVID-19 vaccine, transforming it with factories specializing in antibody treatments and viral gene therapies.

According to the report, builders have already begun construction on one facility, while the land for the other remains undeveloped to this point. FT said the facilities are set to open in 2023 with up to 350 highly skilled jobs to be created in contract manufacturing.

Fujifilm manufactures the active ingredient for the vaccines developed by Novavax, FT said. Novavax’s vaccine was recently submitted to regulators, according to the report, but has not received approval in the UK, while the company said months ago that it intended to file for FDA emergenc…

Owen Mumford starts work on new production center in U.K.

Owen Mumford this week announced that it has started building its new production facility in Witney, Oxfordshire in the U.K.

Owen Mumford’s new Witney facility will stand as a production site for the company’s recently launched, next-generation auto-injector Aidaptus. The company has decades of experience creating its own drug delivery, blood sampling and rapid diagnostic products — as well as creating devices for major pharmaceutical and diagnostics companies.

Get the full story on our sister site, Medical Design & Outsourcing.