Cambridge biotech Agios wins FDA approval for leukemia drug

Cambridge biotech Agios wins FDA approval for leukemia drug

The Food and Drug Administration on Friday approved the first drug in a new class of treatments for acute myeloid leukemia. The drug — developed by Cambridge biotech Agios Pharmaceuticals — is a once-daily pill that might replace chemotherapy for some people with refractory or relapsing AML, a type of blood cancer that forms in […]

High-Risk Medical Device Approval Process in Europe Inches Towards Transparency

High-Risk Medical Device Approval Process in Europe Inches Towards Transparency

But further steps are needed, one expert argues. “It’s impossible to practice evidence-based medicine without access to the evidence.” The European Union (EU) is moving ahead with plans to provide better access to data surrounding the approval of implantable and high-risk medical devices, but a group of experts suggest that full transparency with respect to […]

Trade Bill: Doctors In The Commons Unite To Put NHS Patients First

Trade Bill: Doctors In The Commons Unite To Put NHS Patients First

Robert Ingelhart via Getty Images The Commons recently passed New Clause 17 – making it a negotiating objective for the Government to secure an international agreement, through which the UK may continue to participate in the European medicines regulatory network partnership, between the EU, EEA and European Medicines Agency. It ensures that patients continue to […]

Approval of drug derived from cannabis not necessarily a win for weed

Approval of drug derived from cannabis not necessarily a win for weed

The cannabis plant produces hundreds of different compounds, many of which have differing effects in the body. Tetrahydrocannabinol, or THC, is the substance that is most known for its psychoactive effects, or the “high” associated with marijuana. However, there are many other substances from the cannabis plant that also produce effects in the body. Many […]

PTC Dives Into Gene Therapy with $50M Agilis Biotherapeutics Deal

PTC Dives Into Gene Therapy with $50M Agilis Biotherapeutics Deal

Xconomy New York —  PTC Therapeutics is looking to gene therapy in a bid to broaden its pipeline, scooping up privately held Agilis Biotherapeutics in a cash and stock deal. South Plainfield, NJ-based PTC (NASDAQ: PTCT) will pay $50 million up front, plus $150 million in PTC shares, for Agilis. Agilis, based in Cambridge, MA, […]

BioStem Technologies (BSEM) Subsidiary Nesvik Pharmaceuticals Announces the Completion of An Asset Purchase …

BioStem Technologies (BSEM) Subsidiary Nesvik Pharmaceuticals Announces the Completion of An Asset Purchase …

Pompano Beach, FL, July 19, 2018 (GLOBE NEWSWIRE) — Nesvik Pharmaceuticals (f/k/a BioStem Pharmaceuticals), a subsidiary of BioStem Technologies, Inc. (OTC PINK: BSEM) (“BioStem” or the “Company”), a global life sciences corporation, is pleased to announce the Asset Purchase of multiple New Drug Compounds from CCM Pharma Solutions establishing the beginning of a Joint Venture. […]

3D printing brings novel doses, shapes and characteristics to 'advanced manufacturing', states Aprecia

3D printing brings novel doses, shapes and characteristics to 'advanced manufacturing', states Aprecia

In a blog post​ published this week, Gottlieb wrote on how the US Food and Drug Administration (FDA) needs to take steps to foster a clearer regulatory pathway to what it terms ‘advanced manufacturing’, which include 3D printing and continuous manufacturing. Gottlieb states: “The bottom line is this: Drug makers won’t switch to these systems […]