AACR: BMS, clinging to Opdivo's lung cancer share, highlights long-term data

Opdivo | April 03, 2019

AACR: BMS, clinging to Opdivo's lung cancer share, highlights long-term data
After a hard blow to its hopes in previously untreated lung cancer, Bristol-Myers Squibb is clinging to its share of the second-line market. And it’s hoping new long-term data can help it hang on. Tuesday at the American Association for Cancer Research, the New Jersey drugmaker shared results from a pooled analysis of two phase 3 studies of patients with advanced non-small cell lung cancer who hadn’t received previous treatment. And they showed that at the four-year mark, 14% of all Opdivo-treated patients were still alive, compared with just 5% of those who had received chemo instead. What’s more, 58% of those who had responded to Opdivo at the six-month mark, either partially or completely, were still alive four years later, versus just 12% of chemo patients.

Spotlight

In January 2016, together with the generics and diagnostics industries, we launched a joint Declaration1 to call for collective action from governments and relevant stakeholders against the spread of drug-resistant infections.

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BUSINESS INSIGHTS

Hikma and FAES Farma enter into exclusive licensing agreement for the commercialisation of Bilastine tablets in the US

Hikma Pharmaceuticals PLC | September 21, 2021

Hikma Pharmaceuticals PLC (Hikma), the multinational generic pharmaceutical company, announces the signing of an exclusive US license agreement with FAES Farma S.A. to commercialise Bilastine tablets, a non-sedating second generation antihistamine molecule for the treatment of allergic rhinitis and urticaria. Under the terms of the agreement, Hikma will be responsible for obtaining regulatory approval of Bilastine by the US Food and Drug Administration (FDA) and for the commercialisation of the product in the US following approval. Hikma will provide FAES with an upfront payment, regulatory approval and commercial milestone payments as well as royalties. The agreement builds upon Hikma and FAES Farma's existing partnership on Bilastine in the Middle East and North Africa, where Hikma is the exclusive licensee for Bilastine in 15 countries. We are pleased to form this partnership with FAES Farma for Bilastine, which builds on our growing position in the allergy market and further advances our objective of strengthening our specialty business in the US. Since its first launch in Europe in 2011, Bilastine has been successfully commercialised as a leading allergy brand in more than 100 countries. By introducing Bilastine in the US, Hikma is further solidifying its presence in the allergy market, and we will leverage our existing salesforce promoting our specialty portfolio, including our partnership with Eyevance Pharmaceuticals for the co-promotion of ZERVIATE® and our forthcoming branded seasonal allergic rhinitis nasal spray Ryaltris™. We look forward to bringing this new treatment option to US patients. - Brian Hoffmann, President of Hikma Generics. About Bilastine Bilastine is a non-sedating second generation antihistamine molecule for the treatment of allergic rhinitis and urticaria. Bilastine is currently approved in more than 120 countries and achieved more than €290 million in worldwide sales in 2020. If approved by the FDA, Bilastine would be the first New Chemical Entity antihistamine approved in the US since 2007. About Hikma Hikma helps put better health within reach every day for millions of people around the world. For more than 40 years, we've been creating high-quality medicines and making them accessible to the people who need them. Headquartered in the UK, we are a global company with a local presence across the United States (US), the Middle East and North Africa (MENA) and Europe, and we use our unique insight and expertise to transform cutting-edge science into innovative solutions that transform people's lives. We're committed to our customers, and the people they care for, and by thinking creatively and acting practically, we provide them with a broad range of branded and non-branded generic medicines. Together, our 8,600 colleagues are helping to shape a healthier world that enriches all our communities. We are a leading licensing partner, and through our venture capital arm, are helping bring innovative health technologies to people around the world.

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Coronavirus Vaccine: Johnson & Johnson Pledges 100M Doses to U.S. For $10 Each

Johnson & Johnson | August 06, 2020

With leading COVID-19 vaccines in late-stage testing, companies have been inking supply deals with the U.S. government for a quick rollout if their programs succeed. Now, Johnson & Johnson is getting into the act. The pharma giant struck a deal to supply 100 million doses of its candidate, Ad26.COV2.S, if the shot is cleared for use by the FDA. The U.S. government is committing just over $1 billion under the agreement for a price per dose of about $10. That compares with a lower price-per-dose of $4 for AstraZeneca and a higher figure of $19.50 for Pfizer and BioNTech under agreements between those drugmakers and the U.S. government. J&J and AZ have pledged to provide their vaccines under a not-for-profit basis during the pandemic. Under the new J&J deal, which stipulates manufacturing in the U.S., the feds could later buy another 200 million doses under a separate agreement. The company previously won $456 million in funding to support its R&D and manufacturing scale-up, according to a government database.

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PHARMA TECH

Feds rebuff Pfizer's pleas to speed up supplies of COVID-19 vaccine raw materials

Pfizer | December 21, 2020

Since the time Pfizer was fixed to partake in the U.S. government's Warp Speed exertion to get COVID-19 antibodies to showcase, the organization has made it very clear it didn't have to take any bureaucratic cash to build up the immunization. In any case, did that refusal of R&D subsidizing add to Pfizer's failure to produce more dosages of its mRNA antibody for the U.S. market? Pfizer could give more than the 100 million portions it guaranteed in its unique agreement with the U.S. government in the main portion of one year from now—however just if Trump organization authorities request that providers of crude materials rapidly satisfy the organization's requests. Furthermore, CEO Albert Bourla, Ph.D., is approaching the public authority to utilize the Defense Production Act to do precisely that. The Trump organization hasn't done as such yet on the grounds that they've zeroed in on giving those materials to antibody producers that took government R&D subsidizing, as Moderna, as indicated by anonymous sources who addressed The New York Times. A representative for Pfizer declined to remark, refering to the privacy of conversations with the U.S. government. Yet, Bourla said during a CNBC meet that the organization is in exchanges to sell an extra 100 million dosages of Pfizer's COVID-19 immunization to the U.S. government. "We can give a ton of that in the second from last quarter. The U.S. government needs it in the subsequent quarter," Bourla said in the Monday meet. "We are working cooperatively to attempt to discover an answer and have the option to apportion those 100 million [doses] in the subsequent quarter if conceivable, or a ton of them." Pfizer mentioned almost immediately that the public authority grant it "supported status" with providers of crude materials, however authorities were anxious about the possibility that that would harm contending immunization programs that took government R&D cash, as per the Times report. Among those organizations is Moderna, which is required to win crisis use approval from the FDA for its mRNA immunization this week—and last Friday, inked an arrangement to add 100 million additional portions to its underlying U.S. request.

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Spotlight

In January 2016, together with the generics and diagnostics industries, we launched a joint Declaration1 to call for collective action from governments and relevant stakeholders against the spread of drug-resistant infections.