RegulationMarketing Authorisation February 4, 2019 AstraZeneca’s Forxiga recommended for marketing authorization in EU By PBR Staff Writer The CHMP’s positive opinion for the marketing authorization of Forxiga is for use as an oral adjunct treatment to insulin in adults with T1D. Forxiga, which is a
Clinical TrialsHuman Trials January 31, 2019 Genentech halts two phase 3 AD trials of crenezumab over futility By PBR Staff Writer The two trials, dubbed CREAD 1 and CREAD 2, will be discontinued as a pre-planned interim analysis indicated that crenezumab was not likely to meet their primary endpoint,
RegulationApprovals January 29, 2019 FDA approves Imbruvica combo for treatment-naive CLL patients By PBR Staff Writer Imbruvica in combination with obinutuzumab is said to be the first approved non-chemotherapy combination regimen for treatment-naïve patients with CLL/SLL, which is the most common form of leukemia
Production & SalesMarketing & Sales January 28, 2019 Sobi acquires Synagis US rights from AstraZeneca By PBR Staff Writer The deal also provides Sobi with the right to participate in payments from the US profits or losses for new medicine MEDI8897 in development for RSV-induced LRTI As
Drug DiscoveryResearch & Development January 24, 2019 BridgeBio Pharma raises $299.2m in financing round By PBR Staff Writer BridgeBio Pharma will also use the funds to expand its efforts on the development of medicines for patients with unmet needs. Both existing investors KKR and Viking Global
Drug DiscoveryResearch & Development January 23, 2019 GSK closes acquisition of Tesaro for $5.1bn By PBR Staff Writer Tesaro acquisition will enable GSK to strengthen its pharmaceutical business; and expand its pipeline and commercial capability in oncology. Tesaro president and COO Dr Mary Lynne Hedley said:
Production & SalesMarketing & Sales January 18, 2019 Acrotech to buy seven hematology/oncology products from Spectrum By PBR Staff Writer Under the deal, Spectrum will secure $160m in an upfront cash payment, while up to $140m in regulatory and sales-based milestones. Spectrum Pharmaceuticals president and CEO Joe Turgeon
RegulationMarketing Authorisation January 17, 2019 Janssen gets EC nod for prostate cancer drug Erleada By PBR Staff Writer Erleada is a next generation oral androgen receptor inhibitor approved to treat adult patients with nmCRPC who are at high risk of developing metastatic disease. Apalutamide holds capacity
Drug DiscoveryResearch & Development January 16, 2019 Sanofi to use Biomunex’s BiXAb platform to generate antibody therapeutics By PBR Staff Writer As part of the deal, Sanofi will use the BiXAb platform of Biomunex to generate and enhance bi-specific and multi-specific antibodies. Sanofi will take responsibility for the research,
Drug DiscoveryResearch & Development January 14, 2019 Charles River, Atomwise collaborate on AI-driven drug discovery By PBR Staff Writer Charles River said it is reaffirming the commitment to the future of drug discovery by advancing its integrated, innovative early-stage platform. As part of the deal, the partnership