// Biotech and Pharma Therapeutics

AstraZeneca deals another blow to IL-12, dumping therapy to follow BMS, Merck KGaA out of race
February 9, 2023 / AstraZeneca / Cytokines / Immuno-oncology / Solid Tumor – Big Pharma involvement in IL-12 is fading fast. Days after Bristol Myers Squibb punted its IL-12 fusion protein, AstraZeneca has jettisoned a gene therapy to dial down its interest in the cytokine for the second time in as many quarters. Read Full Article on Fierce Biotech >>
Sanofi, Pfizer join roster of pharmas marshalling relief for Turkey and Syria after deadly quake
February 8, 2023 / Novartis / Bayer / Turkey / Ukraine – As rescue efforts continue in the wake of a cataclysmic earthquake on the border of Turkey and Syria, drugmakers near and far are rushing to offer aid. Novartis and its generics arm Sandoz are putting up $1 million for the cause. At present, the companies are working to identify the right partners to “make sure this support gets to those most in need,” Novartis said in a press release. Read Full Article on Fierce Pharma >>
Do we need new Alzheimer’s scales, or a new perspective on what’s meaningful to patients?
February 7, 2023 / Alzheimer’s Disease / Biomarkers / Clinical Trials / Eisai – Scales to assess Alzheimer’s disease are not nearly sensitive enough to pick up on clinically meaningful changes in progression for patients with early-stage disease. That’s a problem as more and more pharmaceutical companies tackle this patient population with disease-modifying treatments in clinical trials. Read Full Article on Fierce Biotech >>
Despite rapidly emptying pipeline, AstraZeneca stays loyal to vaccine, immune therapy business
February 9, 2023 / AstraZeneca / COVID-19 / Monoclonal Antibodies / Vaccines – Scroll through AstraZeneca’s pipeline of new drug candidates in development and there remains one glaring omission. The Big Pharma that brought one of the world’s most widely used COVID-19 shots to market doesn’t have any more vaccines in development and only has a single new immune therapy in the clinic. Read Full Article on Fierce Biotech >>
Unmind Acquires Frankie Health, Launches New Workplace Mental Health Product
February 6, 2023 / Mental Health / Healthcare / Unmind / Frankie Health – Workplace mental health company Unmind has acquired Frankie Health, also a mental health company for employers, the organizations announced Thursday. Through the acquisition, the combined entity also launched its new product, Unmind Talk.London-based Unmind offers a measurement tool that allows employees to gain insights into their own mental health. Its content library also provides access to exercises and self-guided courses. Additionally, it has educational material for employers on how to create a healthy work environment. Dublin-based Frankie Health, meanwhile, connects employees to a global network of mental health practitioners. Unmind’s customers include Uber, Major League Baseball, British Airways and Ogilvy, while Frankie’s clients include McDonalds and Lattice. Read Full Article on Med City News >>

// 4th Industrial Revolution

Blue Shield of California Adds Virta Health to Network for Diabetes Care
February 7, 2022 / Blue Shield / California / Diabetes / Medicare – Denver, Colorado-based Virta Health’s platform aims to help people reverse type 2 diabetes. Users get a personalized diet program and a coach, and use monitoring devices and an app to track metrics like blood glucose levels and blood pressure. About 5 to 7% of Blue Shield of California’s members have type 2 diabetes, according to Angie Kalousek-Ebrahimi, senior director of lifestyle medicine at the health plan. Read Full Article on Med City News>>
Healthcare Devices Combined with Intelligent Remote Patient Monitoring from OMRON Healthcare
February 7, 2023 / Healthcare / Remote Patient Monitoring / OMRON – RPM is the order of the day for health care. Monitoring, together with providing data-based guidelines for patient behavior, is a crucial component of telehealth and a key building block of value-based care, where an improvement in the patient’s condition is more important than the number of clinical visits. Read Full Article on Healthcare IT Today >>
Merchandising healthcare access: adopting e-commerce techniques
February 8, 2023 / Healthcare / e-commerce / Big Tech – As the consumerization of healthcare continues to take shape, the next frontier of healthcare access may well be merchandising healthcare inventory, contended Derek Streat, cofounder and CEO of DexCare, a digital transformation platform vendor. By combining healthcare and e-commerce technologies and strategies, healthcare provider organizations can dramatically improve the digital discovery of care and access to it for patients, he said. Read Full Article on Healthcare IT News >>
New York approves AI-driven breast cancer diagnostic
February 7, 2023 / AI / Breast Cancer / Women’s Health / New York – Along with New York State Department of Health clinical and analytical validation of this use of array morphology, the results of the PDxBr test were reproducible. “Consistent with our mission of improving healthcare, PDxBr has shown to be an effective prognostic tool to further improve risk stratification over current histopathology methods,” said Wayne Brinster, CEO of PreciseDx, in an announcement. Read Full Article on Healthcare IT News >>
Predictive Analytics Tools Accurately Detect Pediatric Autism
February 7, 2023 / Predictive Analytics / Autism / Detection – According to the study, early detection of autism in childhood is crucial for ensuring patients and their families have access to appropriate behavioral support and resources, which are associated with improved outcomes. To improve early detection rates, the American Academy of Pediatrics recommends universal screening among infants from 18 to 24 months. Despite this recommendation, the Centers for Disease Control and Prevention (CDC) report that in 2018, the median age at earliest known autism diagnosis was 50 months, which the authors posit indicates that most children with autism are being identified too late to benefit fully from early support interventions and resources. Read Full Article on Healthcare IT Analytics >>

// Business & Markets

Bayer names former Roche executive Bill Anderson as new CEO
February 8, 2023 / Bayer / Bill Anderson / CEO – German drugmaker Bayer on Wednesday named veteran pharmaceutical executive Bill Anderson to replace current head Werner Baumann as its next CEO, shaking up the company’s leadership as it tries to fend off activist investors. Read Full Article on Biopharma Dive >>
CVS Health Acquires Oak Street Health for $10.6B in Cash – M&A
February 8, 2023 / CVS / Oak Street Heath – Oak Street Health CEO Mike Pykosz will continue to lead Oak Street Health, which will become part of CVS Health’s recently formed Health Care Delivery organization. Oak Street Health will continue to serve its extensive network of health plan partners and patients – consistent with CVS Health’s payor-agnostic approach to delivering leading solutions. Read Full Article on Hit Consultant >>
After pandemic breather, Big Pharma sees drug development costs rise and returns sink: report
February 8, 2023 / Deloitte / M & A / Pipeline / Return on investment – While COVID-19 may have briefly held down the average cost of developing a drug while inflating the potential returns, the party is well and truly over. At least that’s what a report from Deloitte indicates, with Big Pharma back on the pre-pandemic path of spending ever more to make a medicine with shrinking rewards to show for it. Read Full Article on Fierce Biotech >>
Looking forward to Humira biosimilar launch, Teva leans on Ajovy and Austedo as revenues sink
February 8, 2023 / Teva Pharmaceuticals / Austedo / Ajovy / Biosimilars – Thanks to declines for several of its offerings, Teva global sales slipped 5% year over year in the fourth quarter, landing at $3.88 billion. Specifically, in North America, sales of multiple sclerosis drug Copaxone fell 22% to $101 million, while revenues for Teva’s cancer duo of Bendenka and Treanda slipped 20% to $75 million. Read Full Article on Fierce Pharma >>
Why One VC Thinks Women’s Health Is Poised to Take Off Soon
February 8, 2023 / Women’s Health / Femtech – Recently, Pitchbook data revealed investment dollars were flocking towards women’s health. One venture capitalist isn’t surprised. In a recent interview, Francesca de Quesada Covey, chief investment officer at investment firm TheVentureCity, said she believes women’s health will come into its own in the next few years. Read Full Article on Med City News >>

// Legal & Regulatory

Regeneron wins another FDA nod for powerhouse Eylea despite trial flops
February 9, 2023 / Regeneron Pharma / Eylea / Bayer / FDA – Four years after scoring an approval to treat diabetic retinopathy—a disease that strikes more than a third of those with diabetes and is the primary cause of blindness in the United States—Regeneron’s Eylea has gained an FDA nod for the infant version of the disorder. Read Full Article on Fierce Pharma >>
FDA grants priority review for Sage’s rapid-acting treatment for depression
February 6, 2023 / FDA / Depression / Mental Health – Sage Therapeutics said Monday that U.S. regulators accepted a marketing application for its rapid-acting antidepressant and granted it priority review with a decision date set for early August. Read Full Article on Stat News >>
California lawsuit targets insulin costs as Biden also takes aim in SOTU
February 8, 2023 / California / Lawsuit / Biden / SOTU – Attorney general Rob Bonta last month sued three drug makers and three pharmacy benefit managers, alleging that they have conspired to drive up the cost of the drug, which is widely used by people with diabetes, a group that represents more than 10% of California’s population. Five of the drug makers and PBMs involved – Eli Lilly, Novo Nordisk, Sanofi, CVS Caremark and Optum Rx – rejected the lawsuit’s claims or declined to comment. Efforts to reach Express Scripts were not successful.
Read on Med City News >>
AstraZeneca’s Forxiga nabs expanded heart failure approval in Europe
February 7, 2023 / Farxiga / AstraZeneca / Heart Failure / 2GLT2 Drugs – The drug, known as Farxiga in the U.S., gained a nod in Europe to treat patients suffering from heart failure with any type of left ventricular ejection fraction, including mildly reduced and preserved. Ejection fraction is a measure of the amount of blood that leaves the left ventricle of the heart when it beats and spreads to the rest of the body. Previously, AZ’s drug was only approved for heart failure with reduced ejection fraction. Read on Fierce Pharma >>
Despite high-profile media coverage, FDA balks at GSK’s ‘unprecedented’ Jemperli proposal in rectal cancer
February 7, 2023 / GSK / FDA / Jemperli / PD-1/L1 – Highlighting two “unprecedented” elements, the FDA questioned whether it’s appropriate for GSK to use tumor complete response data from single-arm trials to support an approval in locally advanced rectal cancer, a setting where curing the disease is the goal. The agency raised the concerns in a briefing document prepared for a Thursday meeting of external oncology experts. Read on Fierce Pharma >>

// Research & Development

Bayer begins key tests for closely watched blood thinner
February 8, 2023 / Bayer / Blood Thinner / New tests – Bayer is making one of the largest drug development bets in its history, advancing a pair of Phase 3 trials for a blood-thinning drug it believes can become a top-selling medicine in the future. The drugmaker said Wednesday the first patients have been enrolled in the trials, known respectively as OCEANIC-AF and OCEANIC-STROKE and set to include more than 27,000 patients across 40 countries. The trials represent “one of the largest Phase 3 endeavors Bayer has ever undertaken,” the company said in a statement. Read Full Article on Biopharma Dive >>
Roche races to regulators after matching AstraZeneca’s rare disease blockbuster in phase 3
February 7, 2023 / Roche / Genentech / Soliris / PNH – Roche is ready to wade into the increasingly ferocious fight for the paroxysmal nocturnal hemoglobinuria (PNH) space. The Big Pharma’s subcutaneous contender matched AstraZeneca’s intravenous blockbuster incumbent Soliris in phase 3, positioning it to file for regulatory approvals around the world. Read Full Article on Fierce Biotech >>
Arrowhead confirms J&J’s plan to dial back hepatitis B drug research
February 7, 2023 / Arrowhead / Drug Research / Hepatitis B – Arrowhead Pharmaceuticals’ chief executive on Monday confirmed Johnson & Johnson is dialing back its hepatitis B drug research, leaving the future of a lucrative partnership between the two companies unclear. “We understand that they are deprioritizing HBV broadly,” Arrowhead CEO Christopher Anzalone said on a conference call. “This is all new to us,” he added. “We will assess our options and rights when [J&J] decides the path forward for the program.” Read Full Article on Biopharma Dive >>
Roche Drug for Rare Blood Disorder Hits Phase 3 Goals; Regulatory Filings Are Next
February 7, 2023 / Roche / Blood Disorder / AstraZeneca – A Roche drug in development for treating a rare blood disorder has Phase 3 data showing it worked at least as well as a blockbuster AstraZeneca drug while also offering patients a dosing advantage. With those results in hand, the Swiss drugmaker says it is now planning to seek regulatory approvals worldwide. Read Full Article on Med City News >>
J&J says drug it acquired from Momenta succeeds in study of ultra-rare condition
February 6, 2023 / J&J / Momenta / Nipocalimab – Nipocalimab came from the biotechnology company Momenta Pharmaceuticals, which pivoted from producing biosimilar copycats to developing its own drugs. The change in focus paid off in 2020, when J&J acquired the company for $6.5 billion. The deal gave J&J access to nipocalimab, which targets an immune cell protein in order to shut down unwanted immune responses. It’s being studied for an array of conditions from maternal fetal diseases to rare autoantibody disorders and prevalent rheumatic conditions like arthritis and lupus. Read Full Article on Biopharma Dive >>

// Politics

In address to Congress, Biden touts drug pricing law and pushes insulin cost caps
February 8, 2023 / Biden / Drug Costs / Insulin – Biden called on lawmakers to cap insulin costs at $35 a month for all people with diabetes, a move that would expand a provision of last year’s Inflation Reduction Act that limits the price for people on Medicare. It costs about $10 to produce a vial of insulin, and drugmakers are charging people hundreds of dollars a month for the drug while “making record profits,” Biden said. Read Full Article on Biopharma Dive >>
Biden takes aim at pharma in SOTU speech, vowing to defend IRA from repeal efforts
February 8, 2023 / Joe Biden / Inflation Reduction Act / PhRMA / Drug Costs – Tuesday night in his State of the Union address on Capitol Hill, an emboldened Biden promised to quash any effort by Republicans—now in control of the House of Representatives—to repeal the IRA. “Make no mistake, if you try to do anything to raise the cost of prescription drugs, I will veto it,” Biden said. Read Full Article on Fierce Pharma >>
In State of the Union, Biden pitches addiction, mental health care policies as opportunities for bipartisanship
February 7, 2023 / State of the Union / Biden / Mental Health – “We pay more for prescription drugs than any nation in the world,” he said, referencing a top issue among voters but steering away from the details that have divided Congress’ two parties, instead tapping safe bipartisan priorities like controlling the cost of insulin, which is now capped at $35 in Medicare. Democrats failed last year to extend that cap to Americans in commercial plans. Read Full Article on STAT News >>
Opinion: Pharmalittle: Biden wants $35 insulin cap for all Americans; pharma loses a court case over importing drugs from Canada
February 8, 2023 / Biden / Insulin / Drug Prices – Rise and shine, everyone. The middle of the week is upon us. Have heart, though. You made it this far, so why not hang on for another couple of days, yes? And what better way to make the time fly than to keep busy. So grab that cup of stimulation — our flavor today boasts the aroma of blueberries — and get started. Meanwhile, do keep us in mind if you hear anything interesting. Read Full Article on STAT News >>
Attacking Our Leading Tech Innovators for Political Gain Comes at Our Own Peril
January 31, 2023 / Tech Innovators / Politics / Tech Companies / Biden – The tension over the tech advantage was obvious as President Joe Biden made clear that the United States would “continue to compete vigorously,” while China pushed back on restrictions imposed last month by the US on China’s access to semiconductor technology that can be used to deliver hypersonic missiles or potentially crack the US military’s most advanced codes. Read Full Article on The Defense Post >>