// Biotech and Pharma Therapeutics

A San Diego startup sees covalent biologics as the next frontier in cancer drugs
December 15, 2022 / San Diego / Cancer Drugs / Enlaza Therapeutics / Startup –Enlaza’s approach involves introducing what it describes as “unnatural” amino acids to protein drugs. The addition of this new protein building block helps the drugs form covalent bonds, and in ways that are selective to its target — or at least so Enlaza claims. Enlaza hopes this technology can give it the tools to develop more potent protein drugs, but also ones that can go after cell surface molecules that are usually difficult to reach. Medicines that the company develops would lock onto a tumor, for example, and deliver a payload while still maintaining high systemic clearance, Duron said. Read Full Article on Biopharma Dive >>
ASH: Novartis says rare disease med ‘stands on its own,’ diving deeper into head-to-head win against AstraZeneca
December 13, 2022 / Novartis / ASH 2022 / Astra Zeneca / Alexion – The update, released Tuesday morning at the American Society of Hematology’s annual meeting, expands on results first disclosed by Novartis in October showing iptacopan’s superiority. The latest presentation on the drug for a rare inflammatory condition called paroxysmal nocturnal hemoglobinuria, or PNH, found that more than 80% of treated patients experienced an increase in hemoglobin levels of at least two grams per deciliter without the need for red blood cell transfusions. This compared to just 2% of patients treated with either Soliris or Ultomiris, two market-leading PNH meds owned by AstraZeneca. In an interview with Fierce Biotech ahead of the data release, David Soergel, M.D., Novartis’ head of global drug development for cardiovascular, renal and metabolism, unsurprisingly said he supports full approval of iptacopan based on the “fantastic” readout. Read Full Article on Fierce Biotech >>
ASH: Eli Lilly pads novel BTK’s case amid FDA review. But AbbVie-J&J, BeiGene and AZ need not worry
December 12, 2022 / Eli Lilly / ASH 2022 / B-cell Lymphoma / Non-Hodgkin Lymphoma –Eli Lilly offered updated analyses of BTK inhibitor pirtobrutinib in previously treated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and mantle cell lymphoma (MCL), as well as the first sizable cohorts of Waldenström macroglobulinemia and Richter transformation, at the American Society of Hematology (ASH) 2022 annual meeting. The drug’s proposed use in MCL is expecting FDA decision in January. Existing BTK inhibitors, namely AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa, are all vying for market share in newly diagnosed patients, mainly in CLL/SLL. But Lilly sees “a real opportunity” for pirtobrutinib to treat those who’ve failed one of those current BTK drugs, Jake Van Naarden, CEO of Lilly’s oncology unit Loxo, said in an interview with Fierce Biotech. Read Full Article on Fierce Biotech >>
45 days later, BioCryst abandons another program, citing stiff competition
December 15, 2022 / BioCryst Pharmaceuticals / Drug Development / American Society of Hematology (ASH) –The decision to abandon BCX9930 comes after BioCryst caught a glimpse of its competitors’ hand at the American Society of Hematology meeting last week. After taking a look at what else is out there for diseases including paroxysmal nocturnal hemoglobinuria (PNH) and C3 glomerulopathy, BioCryst determined that BCX9930 would not be competitive. Discontinuing development will have a positive near-term financial impact on the company and clear the way for focus to shift to BCX10013, also an oral factor D inhibitor. BCX9930 was by far BioCryst’s most advanced candidate, with two mid-phase studies underway in PNH as well as a third phase 2 in kidney diseases. Patients in these studies who are seeing benefit will be allowed to continue on the therapy, and the company plans to offer access to BCX10013. Read Full Article on Fierce Biotech >>
Nation’s sole manufacturer of Amoxicillin brand products warns US at ‘substantial risk’
December 14, 2022 / Amoxicillin / Supply Chain / Shortage –According to U.S. Pharmacopeia, 83% of the critically needed raw ingredients that go into making pharmaceutical drugs are based overseas, a supply chain concern that puts the U.S. at a “substantial risk,” according to the nation’s sole manufacturer of Amoxicillin brand products. “About 80% of all antibiotics and many medications are produced in either India or China, or overseas, in any case. And that puts us as a country at substantial risk, not only risk of not having the medications, but it’s, of course, a public health risk. And, a security risk for our country because we become dependent upon some of these other countries,” USAntibiotics President Patrick Cashman told FOX Business’ Lydia Hu. Read Full Article on Dox Buisness >>

// 4th Industrial Revolution

Groundbreaking implants can restore 20/20 vision to the blind and visually-impaired
December 13, 2022 / Vision Impairment / Optometry / Affordable –Researchers and entrepreneurs have developed an implant made of collagen protein from pig’s skin, which resembles the human cornea. In a pilot study, the implant restored vision to 20 people with diseased corneas, most of whom were blind prior to receiving the implant. The study jointly led by researchers at Linköping University (LiU) and LinkoCare Life Sciences AB has been published in Nature Biotechnology. The promising results bring hope to those suffering from corneal blindness and low vision by providing a bioengineered implant as an alternative to the transplantation of donated human corneas, which are scarce in countries where the need for them is greatest. Read Full Article on The Brighter Side >>
Movano Begins Testing Its Smart Ring for Women With Novant Employees
December 14, 2022 / Movano / Women’s Health / Novant / Smart Ring –“It’s designed to be comfortable, accurate and intelligent,” said Movano CEO John Mastrototaro. “The ring measures heart rate, blood oxygen levels, sleep, respiration rate, temperature, activity and more. It delivers value by going beyond a dashboard of graphs and numbers, providing real tools that empower women to take ownership over their health journey.” For the beta program, about 30 Novant employees will wear the ring to evaluate its functionality and wearability. The program will be “an extremely valuable exercise” for Movano because it will enable the company to collect data from a broader group of people, Mastrototaro said. Movano will use the data it collects to fine tune its algorithms and assess how well its ring meets user expectations. Full Article on MedCity News >>
Most Health Systems Are Deploying Home-Based Care to Reduce Hospitalizations & ED Visits, Report Shows
December 13, 2022 / Health Systems / Home-based care / Current Health –The majority of health systems now offer some sort of home-based care program. The biggest goals of these programs are to improve patient outcomes through reductions in readmissions, hospitalizations and emergency room visits, according to a report released Wednesday by Current Health. Current Health is an at-home care platform that was acquired by Best Buy last year for $400 million. For its report, the company partnered with independent research firm Sage Growth Partners to survey 103 hospital and health system leaders. The respondents, who all worked for organizations with more than $100 million in patient revenue, included CEOs, CFOs, CIOs, chief nursing officers and vice presidents of finance. Read Full Article on MedCity News >>
Care.ai Deploys Its Virtual Nursing Software in New Mexico Hospital
December 15, 2022 / Care.ai / Nursing Software / Nurse Shortage – Nurses are leaving their high-stress jobs in droves, with experts predicting the U.S. healthcare system will be short 2.1 million nurses by 2025. To help address this burnout crisis and critical workforce shortage, Nashville-based hospital company Ardent Health Services is adopting virtual nurse technology at its Albuquerque hospital. On Tuesday, Orlando-based healthcare software company Care.ai announced that Lovelace Medical Center in Albuquerque will establish a virtual nursing program using its AI solution. Care.ai, which was founded in 2018, sells a virtual nursing solution that enables virtual nurses to handle patient care and administrative tasks that don’t require physical proximity. The company said Lovelace is one of the first providers to implement its virtual nursing technology, though it can’t share any other customer names at this point. Read Full Article on MedCity News >>
How Should We Transform the Delivery of Women’s Health?
December 15, 2022 / Women’s Health / Digital Health – Today, forecasters estimate the market opportunity for women’s health will exceed $60 billion by the year 2027. Women’s health is no longer considered a niche. At the same time, a new study from the CDC found that more than 80 percent of pregnancy-related deaths are preventable. Access to maternal care has decreased in the last year, according to March of Dimes. And Black women are still dying from pregnancy-related complications at 3-4x the rate of White women. There’s a lot of opportunity to transform the delivery of care for women in this country but there’s also a lot at stake. Read Full Article on MedCity News >>

// Business & Markets

Novartis, busy with its restructuring, sells 5 eye drugs for up to $175M
December 14, 2022 / Novartis / Ophthalmology / Asset Sale – The pharma giant has sold five of its ophthalmic drugs to eye therapy company Harrow for a one-time payment of $130 million, plus additional milestone payments of $45 million. The sale includes cataract surgery recovery eye drops Ilevro and Nevanac, bacterial conjunctivitis eyedrop Vigamox, inflammation eye drops Maxidex and the injectable Triesence. The deal puts Harrow on the map into “a leadership position in the U.S. ophthalmic pharmaceuticals market,” Mark L. Baum, Harrow’s CEO and chairman, said in a statement. Read Full Article on Fierce Pharma >>
Clovis files for bankruptcy
December 12, 2022 / Clovis / Bankruptcy / Cancer Drugmaker / PARP Inhibitor Rubraca –Clovis Oncology, a Colorado-based developer of cancer drugs, said Monday that it has filed for bankruptcy. Founded in 2009, Clovis is perhaps best known for its marketed medicine Rubraca, which targets a prominent protein in cancer research called “PARP” and is approved to treat certain ovarian and prostate cancers. Rubraca, though, has never generated enough revenue to make the company profitable. Over the first nine months of this year, Clovis recorded a net loss of $188 million and, by the end of September, had about $440 million in debt. Read Full Article on Biopharma Dive >>
Sio confirms gene therapy company will be liquidated after tough year
December 15, 2022 / Cell & Gene Therapy / Layoffs / Sio / Liquidated – The outlook was bleak for the New York-based biotech in the spring, when it terminated a licensing agreement with the University of Massachusetts for its GM1 gangliosidosis and GM2 gangliosidosis gene therapies. Those programs had been in the works since December 2018 as potential treatments for two related neurodegenerative disorders. Back in April, CEO David Nassif warned of “significant head count reduction,” with one Sio employee telling Fierce Biotech at the time, “I would be shocked if there are five people that are left.” Read Full Article on Fierce Biotech >>
Praxis ends year on high with $100M biobucks UCB deal for epilepsy medicine
December 14, 2022 / Praxis Precision Medicines / UCB / Epilepsy / Licensing Deals – The collaboration is based upon Praxis’ PRAX-020 program to discover small-molecule therapeutics as potential treatments of KCNT1-related epilepsies, for which there are currently no approved treatments. As well as an upfront payment from the Belgian biopharma, Praxis will be eligible for development and commercial milestone payments to the tune of up to $100 million, on top of royalties. UCB retains an exclusive option to in-license global development and commercialization rights to any KCNT1 small-molecule candidate that results from the agreement. The money will come as welcome news to Praxis, which laid off staff and halted a clutch of clinical trials after its nervous system drug PRAX-114 failed to deliver in a phase 2 study in June. The company moved to prioritize its programs in movement disorders and epilepsy, a decision that appears to have paid off with the UCB deal. Read Full Article on Fierce Biotech >>
Horizon CEO Walbert in line for major payday after Amgen sale
December 15, 2022 / Compensation / M&A / Horizon Therapeutics / Amgen – Horizon Therapeutics CEO Timothy Walbert has made routine appearances in rankings of the biopharma industry’s best-paid executives, and he’s set to collect once again with his company’s sale to Amgen. Walbert is in line for a huge payday if the deal closes as expected in the first half of 2023, according to Horizon securities filings. Amgen on Monday agreed to buy Horizon for $27.8 billion, or $116.50 per share. Walbert is a major shareholder in his company, owning 693,907 shares at the time of the deal. When Amgen purchases those shares at the agreed-upon deal price, Walbert would net around $80.84 million. Read Full Article on Fierce Pharma >>

// Legal & Regulatory

Court swats down Vanda’s patent suit against Teva and Apotex, clearing the way for Hetlioz generics
December 14, 2022 / Vanda Pharmaceuticals / Apotex / Teva Pharmaceuticals / FDA – A federal court in Delaware has not only rejected (PDF) Vanda’s claim of patent infringement against generic drug makers Teva Pharmaceuticals and Apotex, it has ruled that four of Vanda’s patent claims are invalid. With generic competition looming, the prospects for Washington, D.C.-based Vanda are dim. Last year, with sales of $173.5 million, the pill accounted for 65% of the company’s revenue. With news of the defeat, Vanda’s share price tumbled by 33% on Tuesday. Read on Fierce Pharma >>
FDA advisers nix Cytokinetics’ heart failure med, rejecting argument for subgroup use
December 13, 2022 / Cytokinetics / Omecamtiv Mecarbil / FDA / Heart Failure – The decision pours cold water on a mixed bag of data accrued in the second-largest clinical trial of heart failure patients, which the company argued support the use of the drug among patients with worse heart function. Now faced with a February 2023 decision deadline, the FDA will have to decide whether to follow the panel’s vote or whether to approve the medicine. The vote followed a lengthy but consistently focused meeting of the FDA’s Cardiovascular and Renal Drugs Advisory Committee on Tuesday, in which a range of issues varying from study design to safety caused concern among a majority of the committee members. In all, the convened experts concluded that the data at their disposal were murky and too muddled to validate a positive risk-benefit profile. Read on Fierce Biotech >>
Watch out, Amgen. Mirati kicks off KRAS showdown with FDA approval for Krazati
December 12, 2022 / Mirati Therapeutics / Adagrasib / FDA Approvals / KRAS – Mirati Therapeutics’ Krazati, also known as adagrasib, will take on Amgen’s first-to-market Lumakras thanks to an FDA accelerated approval in previously treated KRAS G12C-mutated non-small cell lung cancer (NSCLC).Krazati marks Mirati’s first commercial product, and the biotech will focus on efficacy in its marketing pitch, CEO David Meek told Fierce Pharma in an interview ahead of the approval. J.P. Morgan analyst Eric Joseph, Ph.D., has in late November put Krazati’s risk-weighted peak sales estimate across multiple indications at $1.7 billion but then lowered the number to $1.3 billion a few days ago, as blockbuster hopes for the drug have dwindled since a Keytruda combination readout. Read on Fierce Pharma >>
Cytokinetics heart drug voted down by FDA panel
December 14, 2022 / Cytokinetics / Heart Drug / FDA / Cardiovascular – An expert committee that advises the Food and Drug Administration on cardiovascular medicines on Wednesday voted against an experimental and closely watched treatment for heart failure, dealing a blow to its developer, Cytokinetics. The drug, called omecamtiv mecarbil, is meant to treat a certain kind of heart failure that involves a lessening of the blood pumped through the left ventricle — commonly referred to as reduced ejection fraction. The FDA accepted Cytokinetics’ application in February this year based on results from late-stage clinical testing of the drug. Read on Biopharma Dive >>
Another Humira biosimilar approved by FDA as AbbVie patent expiry looms
December 15, 2022 / Humira / FDA / AbbVie / Amgen –The end of AbbVie’s monopoly promises to be a major event for the pharmaceutical industry. Humira brought in almost $21 billion in sales last year, including more than $17 billion in the U.S. For years, AbbVie has carefully built a wall of patent protections around the drug, extending its market exclusivity well beyond the main U.S. patent’s expiration in 2016. Amgen will be the first company to challenge AbbVie when it introduces its Amjevita biosimilar next month. A raft of other copycat versions — now including Idacio — will enter the market in July. Read on Biopharma Dive >>

// Research & Development

Dishwashers can be very bad for your gut health, study finds

December 14, 2022 / Get Health / Chemical Residue / New Research –Residue from rinse agents is left behind on dishes after they are cleaned in professional-grade dishwashers. This damages the natural protective layer in the gut and can contribute to the onset of chronic diseases, as demonstrated by researchers working with organoids at the Swiss Institute of Allergy and Asthma Research. Whether it’s at a restaurant, at school or in the barracks, commercial dishwashers help plates, glasses and cutlery become squeaky clean and dry in a matter of minutes. Read Full Article on The Brightside>>
AbbVie, Ipsen exit R&D deals to cap off lousy year for Exicure
December 14, 2022 / AbbVie / Ipsen / Exicure / Hair – Exicure’s death spiral began with the revelation that its former neuroscience group leader misreported data on a preclinical program throughout much of the first nine months of 2021 and accelerated when its backup candidate fell short of preclinical expectations. Last month, the biotech warned investors that “there is a significant likelihood” it will file for bankruptcy unless a private placement is consummated. Against that turbulent backdrop, AbbVie and Ipsen have walked away. Allergan, now part of AbbVie, paid $25 million upfront to discover and develop hair loss drugs using Exicure’s spherical nucleic acid technology in 2019. Read Full Article on Fierce Biotech >>
AstraZeneca, Merck hit with 3-month delay for Lynparza’s FDA filing in first-line prostate cancer
December 15, 2022 / Lynparza / AstraZeneca / Merck / FDA – But on Thursday, the companies reported a snag as the FDA has delayed its target date for its decision on Lynparza in metastatic castration-resistant prostate cancer (mCRPC). The agency has pushed back the decision date to March to “provide further time for the full review of the submission,” Merck said. The application is for Lynparza, a PARP inhibitor, to be used in combination with Johnson & Johnson’s androgen inhibitor Zytiga plus the steroid prednisone or prednisone alone for mCRPC patients. Read Full Article on Fierce Pharma >>
Moderna vaccine succeeds in early-stage skin cancer study with Merck’s Keytruda
December 13, 2022 / Moderna / Vaccine / Skin Cancer / Keytruda –Melanoma was the first type of cancer for which Keytruda gained FDA approval because of its sensitivity to attack from immune cells. Moderna’s personalized cancer vaccine, called mRNA-4157/V940, is derived from patient tissue samples. The company uses them to identify tumor cell mutations, which are then used to design a messenger RNA vaccine that will spur a T cell response specific to the patient’s cancer. The combination trial was in the “adjuvant” setting, in which patients first undergo surgical removal of tumors and then undergo treatment to keep cancer from returning. Read Full Article on Biopharma Dive >>
Novartis Tops AstraZeneca With Blood Drug Data at ASH; FDA Is Next Stop
December 13, 2022 / Novartis / AstraZeneca / Blood Drug / Iptacopan – An experimental Novartis drug has bested two blockbuster AstraZeneca medicines in a head-to-head clinical trial with results that investigators say could change how physicians treat a debilitating rare blood disorder that destroys red blood cells. With those data in hand, the drugmaker is now planning to submit applications seeking regulatory approvals starting in 2023. The Novartis drug, iptacopan, is a potential treatment for paroxysmal nocturnal hemoglobinuria (PNH), a disorder of the complement system that leads this part of the immune system to attack red blood cells. The chronic condition can be managed with blood transfusions. The standard of care drugs for PNH are two AstraZeneca products, Soliris and Ultomiris. Read Full Article on MedCity News >>

// Politics

Pfizer’s Supreme Court challenge of US kickback law is ‘far-fetched,’ HHS says
December 15, 2022 / Pfizer / Supreme Court / Department of Health and Human Services / Vyndaqel – The company wants SCOTUS to reconsider a ruling that blocks it from providing rebates to Medicare patients for its pricey heart medications Vyndaqel and Vyndamax. At issue is whether drugmakers should be allowed to use charity programs to help Medicare D patients afford expensive drugs. In recent years, the government has cracked down on the rebate programs to help rein in Medicare spending. Read Full Article on Fierce Pharma >>
Corn group wants US commitment on filing biotech dispute against Mexico
December 14, 2022 / National Corn Growers Association / Biden / U.S. / Mexico –U.S. and Mexican government officials have been meeting over Mexico’s plan to ban on genetically modified corn, but the National Corn Growers Association says time is running out and the Biden administration needs to take action soon. In a letter to President Joe Biden, NCGA are seeking a deadline for initiating a dispute settlement process under the U.S.-Mexico-Canada agreement if Mexico does not withdraw its presidential decree that would stop all imports of GM corn from the U.S. in January, 2024. “Corn farmers are right now in the process of making planting decisions for next spring, and any additional uncertainty in the market affects their ability to appropriately respond to multiple market signals,” NCGA said in the letter. “If the decree is not completely withdrawn, we ask that your administration initiate a case under USMCA.” Read Full Article on Agri Pulse >>
Food biotechnology often becomes a political issue, rather than a policy issue
December 14, 2022 / Food Biotechnology / Biden / Politics –Martijn Pakker is Senior Manager for Communication, Stakeholder Engagement and Global Advocacy at the International Rice Research Institute, the organisation responsible for developing golden rice. Golden Rice has been awaiting approval in Bangladesh for more than five years now. Pakker talks about the potential benefits of golden rice and the use of biotechnology in food in general, while also addressing many of the doubts and fears linked to genetically modified food (GMO). Read Full Article on The Business Standard >>
Biden’s drug pricing decisions aren’t over
December 13, 2022 / Biden administration / Drug Costs / Congress / Medicare –The Biden administration faces a host of high-stakes decisions on prescription drug costs over the next several months, accompanied by pressure from congressional Democrats eager for a sequel to pricing components in the Inflation Reduction Act (IRA). The big picture: Democrats just delivered on their decades-long promise to allow Medicare to negotiate drug prices. But that legislative victory kicked off a series of difficult decisions the administration will have to make as it decides how much further to go addressing costs. Read Full Article on AXIOS >>
AbbVie receives shareholder proposal on political congruence
December 13, 2022 / AbbVie / Politics LGBTQ / Shareholder –AbbVie potentially faces a vote on a shareholder proposal seeking information on how its stated positions line up with its political spending. The resolution has been filed amid growing scrutiny of companies’ values and political positions but also pushback from some lawmakers and investors against them taking public stances on issues such as LGBTQ+ rights. As You Sow has filed a resolution with the pharmaceutical company asking that each year it analyze and report on the congruence of its political, lobbying and election expenditures against its publicly stated company values and policies. Read Full Article on Corporate Secretary >>