Pharma Industry

The man behind one of the top manufacturers for the U.S. Strategic National Stockpile is parting ways with the company after more than 20 years.  Fuad El-Hibri, founder and executive chairman of CDMO Emergent BioSolutions, will retire on April 1, the company said Friday.  The parting is amicable. “While I have been looking forward to

A World Health Organization (WHO) panel has given the green light to two new drugs to treat COVID-19. US-based Eli Lilly’s baricitinib (Olumiant), a Janus kinase inhibitor, and GlaxoSmithKline and Vir Biotechnology’s sotrovimab, a monoclonal antibody, were recommended in new WHO guidelines, published in the British Medical Journal.  Baricitinib, administered with corticosteroids, was strongly recommended as

The details are slim, but Novo Nordisk seems to be in the clear after shareholders took the diabetes juggernaut to court nearly three years ago over the company’s public communications about its struggling insulin business. Novo Nordisk said Friday that it’s settled a Danish securities lawsuit from the summer of 2019. The agreement “contains no

The European Commission, EMA and national regulators within the EU have launched an initiative to change the way clinical trials are designed and run in order to position the bloc as an international “focal point” for clinical research. The broad strokes of the proposals are laid out in a document entitled Accelerating Clinical Trials in

Look out, Sanofi and Regeneron: Pfizer is on the scene in atopic dermatitis with another blockbuster-to-be.  Friday, the FDA approved the New York drugmaker’s oral daily JAK1 inhibitor Cibinqo to treat adults with moderate to severe atopic dermatitis who have not been able to get their disease under control with other medicines including biologics and

Japanese pharma group Otsuka has led a $10 million first-round financing of GrayMatters Health, an Israeli company developing a digital health approach to the management of mental illness. Otsuka Medical Devices is also taking some rights to GrayMatters’ platform – called Prism – in Japan and some other Asian countries in connection with the financing,

About a month after Martin Shkreli’s former company inked a $40 million settlement to resolve allegations of anticompetitive conduct on toxoplasmosis drug Daraprim, the “pharma bro” has learned his fate in his own antitrust case.  A federal judge ordered the former Turing executive to pay $64.6 million in disgorgement related to money he earned from

In the latest episode of the pharmaphorum podcast, Dr Paul Tunnah speaks to head of Patient Engagement at Syneos Health, Marie Emms, and Elligo Health Research vice president, strategic partnerships, Keith Fern. Together they discuss the changing nature of clinical trials how COVID-19 impacted the sector, and the role technology is playing in supporting trial

After a false start in Europe, bluebird bio is determined to give its trio of gene therapies a better shot in the U.S.  Bluebird is readying the commercial nest ahead of a May decision on its beta thalassemia gene therapy beti-cel, also known as Zynteglo. Those preparations will be “crucial” to unlocking the blockbuster potential

The US Supreme Court handed down two decisions today relating to COVID-19 vaccine mandates, issuing a stay to prevent a broad mandate from the Occupational Health and Safety Administration, but allowing a more limited Centers for Medicare and Medicaid Services mandate relating to healthcare workers. The OSHA mandate, due to kick in this week, would

Order up. Shortly after topping off supplies of COVID-19 drugs from Pfizer and GlaxoSmithKline, the U.S. has asked for a second helping of AstraZeneca’s antibody combo. The government has purchased an additional 500,000 doses of AZ’s long-acting antibody cocktail Evusheld, or tixagevimab plus cilgavimab. That comes on top of 700,000 doses the U.S. already ordered,

Roche has launched what it says is a first-of-its kind handheld glucose management device, backed up by a digital platform that aims to simplify the work of doctors and nurses as they deliver care to patients. The cobas pulse system is a point-of-care device that combines a glucose test strip reader with a touch screen

Ahead of its state-of-the-company address at the J.P. Morgan Healthcare Conference, AbbVie took the unusual step of reconfirming its guidance for its blockbusters-in-waiting Rinvoq and Skyrizi, saying it expects the duo’s sales to reach a combined $15 billion in 2025. Why update an estimate that hasn’t changed? While AbbVie expects the two to produce the

As the COVID-19 pandemic continues to impact the healthcare landscape, and the digital transformation of the life sciences industry gathers pace, what can we expect to see in 2022? In this webinar, senior members from Healthware Group discuss the key trends and developments set to shape the industry and present their predictions for the year

When Bristol Myers Squibb unveiled its massive Celgene buyout ahead of 2019’s J.P. Morgan Healthcare Conference, executives knew Celgene’s blockbuster blood cancer drug Revlimid would face generics sometime in the years that followed. In 2022, the key patent cliff is here. Fear not, BMS CEO Giovanni Caforio assured investors on Monday. Opening the conference’s 2022

Swiss biotech Idorsia has claimed FDA approval for its first product – insomnia treatment Quviviq – setting up a market challenge to class rivals from Merck & Co and Eisai. The US regulator has cleared two doses of dual orexin receptor antagonist (DORA) Quviviq (daridorexant) – 25 mg and 50 mg – for the treatment

Rather than 75 years, it will now take about eight months for the FDA to make public the information it used to license Pfizer and BioNTech’s COVID-19 vaccine—provided the regulator can keep up with the new schedule. U.S. district judge Mark Pittman on Thursday ordered the FDA to produce all remaining data on the vaccine

US medical device company Abbott has said it plans to launch a new range of ‘biowearable’ health devices aimed at consumers, in a move that builds on its expertise in glucose monitoring. The company’s chief executive – Robert Ford – made the announcement at the massive CES tech trade show in Las Vegas, a venue

COVID-19 vaccine developers have enjoyed a windfall and so have their chief executives. Now, a group of investors are asking the companies to improve vaccine equity by heaping pressure at the C-suite level. Pay packages for CEOs at COVID vaccine makers Pfizer, Johnson & Johnson, Moderna and AstraZeneca should be tied to making their shots

Kidney cancer is the 14th most common cancer, with approximately 400,000 new cases worldwide every year. Renal cell carcinoma (RCC) is by far the most prevalent type of cancer originating from the kidney, making up nine out of ten kidney cancer diagnoses. As chief medical officer, head of global medical affairs, patient safety and patient