BC Extra | Jan 7, 2020
Company News

Jan. 6 Company Quick Takes: China approvals for AZ, Sanofi and Gene+; plus Apollomics-GlycoMimetics, Pfizer-Merck KGaA and more

Trio of approvals from China’s NMPA   China’s National Medical Products Administration approved NDAs for Lokelma sodium zirconium cyclosilicate from AstraZeneca plc (LSE:AZN; NYSE:AZN) to treat hyperkalemia and anti-PCSK9 mAb Praluent alirocumab from Sanofi (Euronext:SAN;...
BC Innovations | Dec 11, 2019
Product Development

The writing has been on the wall for Sanofi’s diabetes, CV business for years

One hundred days after taking the helm as CEO, Paul Hudson has outlined a plan to get Sanofi to 30% margins by 2022 that hinges largely on the success of Dupixent and five other priority...
BC Extra | Nov 26, 2019
Company News

After mid-decade makeover, Medicines Co. accepts Novartis' $9.7B bid on eve of inclisiran submission

Novartis’ $9.7 billion acquisition of The Medicines Co. gives the pharma an RNAi-based cholesterol-lowering therapy that could capture a larger share of the cardiovascular disease market than approved PCSK9 inhibitors have been able to grab....
BC Extra | Sep 25, 2019
Clinical News

RNAi therapy hits cholesterol endpoints in two more Phase IIIs ahead of Medicines Co.'s submission

With readouts now in from three pivotal trials, Medicines Co. could seek a claim of reduced CV risk in its planned regulatory submissions of inclisiran for LDL-C reduction. The announcement of results from the latest...
BC Extra | Sep 3, 2019
Clinical News

RNAi therapy from Medicines Co., Alnylam cuts cholesterol by 54%, could compete with PCSK9 mAbs

The Medicines Co. announced data from a Phase III trial of inclisiran showing reductions in LDL-C that appear to be competitive with approved mAbs against PCSK9, but with a dosing advantage. Safety data from the...
BC Extra | Aug 28, 2019
Company News

Aug. 28 Company Quick Takes: Amgen to appeal Repatha ruling and EcoR1 buys Woodford’s stake in Prothena; plus DarwinHealth-Celgene, CRISPR IP, Trevena and Shink

Repatha patents invalid, court finds  Amgen Inc. (NASDAQ:AMGN) said it will appeal after a federal court found that its patents covering anti-PCSK9 mAb Repatha evolocumab are invalid on the basis of lack of enablement. The...
BC Extra | Aug 26, 2019
Clinical News

Inclisiran lowers LDL-C in ORION-11, clearing first Phase III hurdle

Data showing whether Medicines Co.'s inclisiran has more than a dosing advantage over anti-PCSK9 mAbs will come next week as the biotech reported top-line results Monday. The Medicines Co. (NASDAQ:MDCO) said the siRNA against PCSK9...
BC Extra | Aug 14, 2019
Clinical News

Regeneron data could set up first-in-class approval in lipid-lowering indication

Regeneron's evinacumab could give certain hypercholesterolemia patients a new treatment option, with an FDA submission looming based on new results from a Phase III trial evaluating the first-in-class therapy as an add-on to existing treatments....
BC Extra | Apr 29, 2019
Company News

April 29 Quick Takes: Takeda, Emendo, ViiV, Zynquista, Benlysta and more

Takeda considering value-based pricing in EU  Takeda Pharmaceutical Co. Ltd. (Tokyo:4502; NYSE:TAK) is mulling employing a value-based pricing model in Europe for Alofisel darvadstrocel, a stem cell therapy to treat complex perianal fistulas in patients...
BioCentury | Apr 6, 2019

Big caps under pressure

Biogen’s fall in the wake of its decision to discontinue late-stage trials of Alzheimer’s therapy aducanumab is yet another reminder that large caps are in dire need of new pipeline products, and could serve as...
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