Jardiance Becomes First SGLT2 Inhibitor to Show Benefit in HFpEF
July 7, 2021 Cardiovascular / Diabetes / Pharmaceuticals Eli Lilly and Boehringer Ingelheim have revealed positive results from a Phase III study of its SGLT2 inhibitor Jardiance in patients with heart failure with preserved ejection fraction (HFpEF). The EMPEROR-Preserved trial has shown Jardiance (empagliflozin) can significantly reduce the risk of cardiovascular death or hospitalisation in adults living with HFpEF, with or without diabetes. In a statement, the two pharma companies said the results establish Jardiance as the first SGLT2 inhibitor treatment to show benefit for HFpEF patients. Read Full Article on Pharma Times >>
July 7, 2021 Cardiovascular / Diabetes / Pharmaceuticals Eli Lilly and Boehringer Ingelheim have revealed positive results from a Phase III study of its SGLT2 inhibitor Jardiance in patients with heart failure with preserved ejection fraction (HFpEF). The EMPEROR-Preserved trial has shown Jardiance (empagliflozin) can significantly reduce the risk of cardiovascular death or hospitalisation in adults living with HFpEF, with or without diabetes. In a statement, the two pharma companies said the results establish Jardiance as the first SGLT2 inhibitor treatment to show benefit for HFpEF patients. Read Full Article on Pharma Times >>
ICER Says Price of Biogen’s Aduhelm Should Be Much Lower
July 1, 2021 Alzheimer’s / FDA / Pricing The Institute for Clinical and Economic Review (ICER) has released a revised report on Biogen’s Aduhelm, saying the Alzheimer’s disease drug should be offered at a much lower price than it current $56,000 per year price tag. Following its surprise approval in June, Biogen announced that it would price its controversial Alzheimer’s disease drug at $56,000 per year of treatment. The high list price for Aduhelm (aducanumab) has since been met with criticism, with ICER adding in its report that the $56,000 per year is ‘not a fair price’ for the treatment. Read Full Article on PM Live >>
July 1, 2021 Alzheimer’s / FDA / Pricing The Institute for Clinical and Economic Review (ICER) has released a revised report on Biogen’s Aduhelm, saying the Alzheimer’s disease drug should be offered at a much lower price than it current $56,000 per year price tag. Following its surprise approval in June, Biogen announced that it would price its controversial Alzheimer’s disease drug at $56,000 per year of treatment. The high list price for Aduhelm (aducanumab) has since been met with criticism, with ICER adding in its report that the $56,000 per year is ‘not a fair price’ for the treatment. Read Full Article on PM Live >>
Aduhelm’s Accelerated Approval Offers a Promising Roadmap for Rare Neurological Diseases
July 7, 2021 Alzheimer’s / FDA / CNS The FDA’s decision to grant accelerated approval to Biogen’s aducanumab (Aduhelm) for the treatment of Alzheimer’s disease was a difficult and bold one that people with the disease, their families, and other drug developers should be applauding. When it comes to making new therapies for complex, difficult-to-treat diseases, history has shown that progress can’t be made without taking a first — often controversial — step. Without the FDA’s accelerated approval program and novel first treatments based on new and imperfect biomarker endpoints, HIV would not be a controllable disease today, and we might not have such a flourishing clinical research ecosystem in oncology. Read Full Article on Stat News >>
July 7, 2021 Alzheimer’s / FDA / CNS The FDA’s decision to grant accelerated approval to Biogen’s aducanumab (Aduhelm) for the treatment of Alzheimer’s disease was a difficult and bold one that people with the disease, their families, and other drug developers should be applauding. When it comes to making new therapies for complex, difficult-to-treat diseases, history has shown that progress can’t be made without taking a first — often controversial — step. Without the FDA’s accelerated approval program and novel first treatments based on new and imperfect biomarker endpoints, HIV would not be a controllable disease today, and we might not have such a flourishing clinical research ecosystem in oncology. Read Full Article on Stat News >>
Heron Therapeutics Announces U.S. Commercial Launch and Availability of ZYNRELEF™ for the Management of Postoperative Pain for up to 72 Hours
July 1, 2021 Pain / Product Launch Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, today announced ZYNRELEF (bupivacaine and meloxicam) extended-release solution, is now commercially available at all national wholesalers and the largest specialty distributors in the United States. Read More on San Diego Biotech Networks >>
July 1, 2021 Pain / Product Launch Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, today announced ZYNRELEF (bupivacaine and meloxicam) extended-release solution, is now commercially available at all national wholesalers and the largest specialty distributors in the United States. Read More on San Diego Biotech Networks >>
20 Reasons Why Strategy Execution Fails
September 10, 2019 Strategy / Leadership Vault realizes this is not a current article…but, deems it very relevant to this weeks wrap up. The success rate of strategy execution is incredibly low. The fail percentages found in scientific studies range from as low as 7 % to as high as 90 %, with an average of about 50% (as reported in a 2015 review article by Candido and Santos in the Journal of Management & Organization). Even though a slight improvement can be seen over the years, such percentages of failure are not particularly satisfying. After all, it means that every second strategy initiative fails to be executed properly. Read Full Article on Forbes >>
September 10, 2019 Strategy / Leadership Vault realizes this is not a current article…but, deems it very relevant to this weeks wrap up. The success rate of strategy execution is incredibly low. The fail percentages found in scientific studies range from as low as 7 % to as high as 90 %, with an average of about 50% (as reported in a 2015 review article by Candido and Santos in the Journal of Management & Organization). Even though a slight improvement can be seen over the years, such percentages of failure are not particularly satisfying. After all, it means that every second strategy initiative fails to be executed properly. Read Full Article on Forbes >>
Midsize Pharmaceutical Firms Are the Industry’s Big Deal Makers This Year
July 5, 2021 Pharma Deals / Capital / Industry Growth Midsize pharmaceutical companies are the industry’s big deal makers this year, replacing larger brethren as new sources of capital emerge. Typically the biggest drugmakers do the most deals by value. Yet large-cap pharmaceutical companies have pulled back on acquisitions this year, as they pay down debt from previous sprees and resist high premiums. Instead, medium-size pharmaceutical companies, which had been targets of their larger peers, have spent the most on acquisitions fueled by the new sources of capital and the need to find growth for the long haul. Read Full Article on WSJ.COM >>
July 5, 2021 Pharma Deals / Capital / Industry Growth Midsize pharmaceutical companies are the industry’s big deal makers this year, replacing larger brethren as new sources of capital emerge. Typically the biggest drugmakers do the most deals by value. Yet large-cap pharmaceutical companies have pulled back on acquisitions this year, as they pay down debt from previous sprees and resist high premiums. Instead, medium-size pharmaceutical companies, which had been targets of their larger peers, have spent the most on acquisitions fueled by the new sources of capital and the need to find growth for the long haul. Read Full Article on WSJ.COM >>
Fujifilm Continues to Expand its Biologics CDMO Business, Ploughing Further $850m into US and UK Sites July 8, 2021 Investment / Biologics / Manufacturing Fujifilm Corporation has made an additional US$850m investment to enable the expansion of its BIO-CMDO sites in the UK, at Billingham, and in the US. Read Full Article on Biopharma Reporter >>
Gates Foundation backs COVID R&D at AI firm Exscientia
July 8, 2021 R&D / Artificial Intelligence Artificial intelligence-based drug discovery company Exscientia is stepping up its search for new COVID-19 medicines, thanks to an award by the Bill & Melinda Gates Foundation. The $1.5 million grant will be used to develop a new class of small-molecule inhibitors of Mpro, a protease enzyme essential for the replication of the SARS-CoV-2 virus. Exscientia said inhibitors of the enzyme could be used as a standalone antiviral therapy against SARS-CoV-2 as well as other coronaviruses, or as part of combination therapy with other drugs. Read Full Article on Pharma Phorum >>
July 8, 2021 R&D / Artificial Intelligence Artificial intelligence-based drug discovery company Exscientia is stepping up its search for new COVID-19 medicines, thanks to an award by the Bill & Melinda Gates Foundation. The $1.5 million grant will be used to develop a new class of small-molecule inhibitors of Mpro, a protease enzyme essential for the replication of the SARS-CoV-2 virus. Exscientia said inhibitors of the enzyme could be used as a standalone antiviral therapy against SARS-CoV-2 as well as other coronaviruses, or as part of combination therapy with other drugs. Read Full Article on Pharma Phorum >>
FDA Medical Device Ban Overturned For the First Time
July 7, 2021 Medical Devices / Graduated Electronic Decelerators In the first challenge ever brought against FDA’s rarely used power to ban a medical device, a court found FDA overstepped its authority and overturned the ban. In March 2020, FDA issued a final rule that banned the use of Graduated Electronic Decelerators (GEDs) to treat patients with severe self-injurious and aggressive behaviors (SIB/AB), but did not restrict the use of these same devices for other purposes, like smoking cessation. Read Full The FDA Law Blog >>
July 7, 2021 Medical Devices / Graduated Electronic Decelerators In the first challenge ever brought against FDA’s rarely used power to ban a medical device, a court found FDA overstepped its authority and overturned the ban. In March 2020, FDA issued a final rule that banned the use of Graduated Electronic Decelerators (GEDs) to treat patients with severe self-injurious and aggressive behaviors (SIB/AB), but did not restrict the use of these same devices for other purposes, like smoking cessation. Read Full The FDA Law Blog >>
Ready for Takeoff: Life Sciences Startups Launch in Canada and Colorado
July 7, 2021 Neurology / Alzheimer’s / Pharmaceuticals Two life sciences companies from two very different areas of medicine announced launches today: Nimium Therapeutics in Montreal focusing on Cardiometabolic Diseases and VitriVax in Boulder, Colorado who closed on Series A Financing to Advance Vaccine Technology. Read Full Article on BioSpace >>
July 7, 2021 Neurology / Alzheimer’s / Pharmaceuticals Two life sciences companies from two very different areas of medicine announced launches today: Nimium Therapeutics in Montreal focusing on Cardiometabolic Diseases and VitriVax in Boulder, Colorado who closed on Series A Financing to Advance Vaccine Technology. Read Full Article on BioSpace >>
