Palbociclib (also known as compound number PD-0332991) is an experimental drug for the treatment of breast cancer being developed by Pfizer. It is a selective inhibitor of the cyclin-dependent kinases CDK4 and CDK6.
The French pharma giant Sanofi announced this morning that it will buy the Belgium-based antibody drug developer Ablynx for $4.8 billion in cash. The deal will further bolster Sanofi’s rare blood disease portfolio and pipeline and gives it access to Ablynx’s small-sized antibodies, called nanobodies.
Sanofi emphasized that the long-term value lies in Ablynx’s nanobody technology. Normal antibodies are composed of two main segments, a heavy chain and light chain. Nanobodies are heavy-chain-only antibodies that are derived from camels and llamas. The end result is a smaller-than-normal antibody drug that can be delivered more easily.
Just months after picking up Advanced Accelerator Applications in a $3.9 billion buyout, Novartis is getting a quick boost with the U.S. approval for Lutathera. The FDA approved the first-in-class med as a treatment for rare cancers of the digestive tract the other day.
Lutathera is first the peptide receptor radionuclide therapy to win U.S. approval, according to a release from AAA. Approved to treat somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), the drug works by binding to the receptors and then using radiation to fight cancer.
Jefferies analysts have predicted $500 million to $1 billion in peak sales for the drug, while Baader Helvea analyst Bruno
Bulic has been more optimistic. At the time of the AAA acquisition by Novartis last year, he predicted $2 billion in peak sales, according to Reuters.
Launching what is expected to be a busy year for drug industry acquisitions, Celgene says it will acquire the CAR T-cell cancer immunotherapy company Juno Therapeutics for about $9 billion, and Sanofi has signed a deal to buy the rare blood disease company Bioverativ for nearly $11.6 billion.
Last year was a slow one for drug industry mergers and acquisitions, with only a handful of deals surpassing $1 billion. Analysts are forecasting a heavier M&A season for 2018, and that prediction looks on track so far.
Juno’s pipeline is entirely based on CAR T-cell immunotherapy, a gene therapy in which a cancer patient’s immune cells are removed from their body, turbocharged via genetic engineering, and reinjected to target cancer. Bioverativ’s biggest selling points are its marketed blood clotting factor replacement therapies for hemophilia, although it’s also working on gene therapies for the disease.
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After a dip in 2016, 2017 brought a two-decade peak in drug approvals. The U.S. Food & Drug Administration gave its green light to 46 new molecular entities, the highest number since 1996. Cancer treatments and drugs for rare diseases continued to command a hefty portion of approvals, and many benefited from an agency that seems motivated to streamline development for truly innovative medicines.
Early on in 2017, it was clear the year would bring a bountiful crop of new medicines. By mid-June, FDA had given its nod to as many new molecules as were approved in all of 2016.
The prior year’s meager output meant many big companies were in need of a rebound in productivity. And indeed, for some, 2017 was a salve. AstraZeneca, for example, had no approvals in 2016. It now has three new products in its portfolio: two cancer treatments and an asthma drug.
New molecular entities approved in 2017: 46
Approved in 2016: 22
63% Small molecules approved, 12 Cancer drugs approved in 2017. While only 4 Approved in 2016.
37% Drugs with “breakthrough therapy” status. Annual price of treatment with BioMarin’s Brineura is $702,000
Novartis and Biocon, which have each had success developing biosimilars on their own, will now see what they can do together. The two have formed a partnership to produce “next generation” biosimilars.
They announced the collaboration today saying they would share the costs equally for developing and commercializing multiple biosimilars in immunology and oncology. Sandoz, the generics unit of Novartis, will market them in the U.S., Canada and most of Europe, while India’s Biocon will take the rest of the world.
They said the partnership is an important part of their strategy to address the “next wave of biosimilar opportunities globally.”