// Biotech and Pharma Therapeutics

VBI Vaccines pares down pipeline and staff to focus on hepatitis B programs
 April 4, 2023 / VBI Vaccines / Layoffs / Hepatitis B / Covid-19 – The company will zero in on approved hepatitis B vaccine PreHevbrio and another candidate called VBI-2601, according to a Tuesday press release. VBI is positioning VBI-2601 as an immunotherapeutic that can be part of a functional cure regimen for patients with chronic hepatitis B. Read Full Article on Fierce Biotech >>
Seeking full approval in Alzheimer’s, Eisai dives into prominent Leqembi side effect
April 4, 2023 / Eisai / Biogen / Iecanemab / Alzheimer’s Disease – As Eisai and Biogen work to cement the clinical profile of their amyloid-busting antibody lecanemab—now sporting an accelerated approval as Leqembi—the companies have plunged headfirst into one of the drug’s most familiar side effects. Read Full Article on Fierce Pharma >>
Reeling from AstraZeneca’s termination of pneumonia collab, Aridis lays off 20% of staff
 April 3, 2023 / Aridis Pharmaceuticals / AstraZeneca / Layoffs / Job Cuts – As part of their 2021 agreement, Aridis agreed to pay $11 million upfront to AstraZeneca’s MedImmune unit for the rights to the monoclonal antibody suvratoxumab. The deal also gave AstraZeneca an equity stake in Aridis and allowed the Big Pharma first negotiations on future licensing as well as potentially $115 million to follow in milestone payments. Read Full Article on Fierce Biotech >>
BioNTech Adds Two ADCs in Second Deal in as Many Months
April 3, 2023 / BioNTech / ADCs – Shanghai-based Duality Biologics will receive $170 million upfront for rights to two of its topoisomerase-1 inhibitor-based ADCs. The lead candidate, DB-1303, is directed against human epidermal growth factor receptor 2 (HER2), a target overexpressed in a wide range of cancers causing aggressive growth and spread. Read Full Article on Biospace >>
Amid dispute with FDA, Akebia proposes new dosing for oral anemia drug in kidney disease
April 3, 2023 / Akebia Therapeutics / Vafseo / Chronic Kidney Disease / Anemia Drugs – Akebia Therapeutics isn’t giving up on its oral anemia drug vadadustat despite an FDA rejection and a partnership gone awry. Now, just as the company challenges the FDA decision, Akebia has offered top-line data for a reduced dosing regimen. Read Full Article on Fierce Pharma >>

// 4th Industrial Revolution

How AI can Tackle the Rising Tide of Staff Shortages in Healthcare
 April 3, 2023 / AI / Healthcare / Staff Shortages- The average number of patients per primary care doctor is at an all-time high of 20 per day. It is not only the physicians suffering but also the clinicians and vital support staff that are the backbone of healthcare as a whole – whether in private practices, hospitals, or urgent care clinics. Read Full Article on Healthcare IT Today >>
How ChatGPT Is Helping Doctors Take Better Patient Notes
 April 3, 2023 / ChatGBT / AI / Healthcare – You’ve probably been hearing a lot about ChatGPT lately, as it’s a major disruptor in the field of generative AI language models. Many professionals worldwide are exploring its potential applications, but others are concerned that it may take over their jobs or generate fake science and news. It’s important to note that generative AI is still in its early stages, and as Bill Gates recently pointed out, these concerns will only become more pressing over time. Read Full Article on Health Tech Insider >>
Uber Health adds same-day prescription delivery
 April 3, 2023 / Uber Health / Healthcare / Prescription Delivery / ScriptDrop – Uber Health, the healthcare arm of transportation company Uber, announced the launch of an additional offering on its platform that allows users to manage same-day prescription delivery. Read Full Article on Mobi Health News >>
FDA drafts AI-enabled medical device life cycle plan guidance
 April 3, 2023 / FDA / AI / Medical Devices / New Tech – The agency says it is proposing a science-based approach to requirements for medical devices powered by artificial intelligence and machine learning that would help deploy new devices faster. Read Full Article on Healthcare IT News >>
ChatGPT Has Potential to Help Cirrhosis, Liver Cancer Patients, Cedars Sinai Study Reveals
 April 5, 2023 / Chat GBT / AI / Liver Cancer / Cirrhosis / New Tech – Patients diagnosed with liver cancer and cirrhosis, an end-stage liver disease that is also a major risk factor for the most common form of liver cancer, often require extensive treatment that can be complex and challenging to manage. Personalized education AI models could help increase patient knowledge and education, noted Alexander Kuo, MD medical director of Liver Transplantation Medicine at Cedars-Sinai, and co-corresponding author of the study. Read Full Article on HIT Consultant >>

// Business & Markets

Biogen taps a deals expert in latest C-suite appointment
April 4, 2023 / Biogen / C-suite / NodThera – Biogen said Tuesday it has hired a head of corporate development to help advance the company’s strategy and pursue “external collaborations and other growth opportunities.” Read Full Article on Biopharma Dive >>
Gene therapy startup Vedere to close two years after launch
 April 2, 2023 / Gene Therapy / Vedere / Novartis / Startup – The startup, a successor to an eye gene therapy biotech that Novartis bought in 2020, will wind down after preclinical experiments didn’t meet the bar set by its leaders. Read Full Article on Biopharma Dive >>
GSK will have to pay additional royalties to AstraZeneca on cancer drug Zejula
 April 5, 2023 / AstraZeneca / GSK / Zehula / Tesaro – The ovarian cancer treatment generated (PDF) 463 million pounds sterling ($571 million) in 2022, representing a 17% increase from the previous year. So far, so good, right? Read Full Article on Fierce Pharma >>
Mark Cuban Cost Plus Drug Company partners with Latino-focused care startup
 April 4, 2023 / Mark Cuban / Zocalo Health / Cost Plus Drug Company – Seattle-based Zócalo Health, a virtual healthcare service for Latino patients, is collaborating with Mark Cuban Cost Plus Drug Company (MCCPDC) to expand its members’ access to lower-cost prescription medication. Read Full Article on Mobi Health News >>
Scorpion snags $553M deal with Pierre Fabre for 2 preclinical lung cancer assets
April 4, 2023 / Scrpion Therapeutics / Emerging Biopharma / Pierre Fabre / Biotech Deals – French pharma Pierre Fabre is offering up to $553 million in biobucks to work with Scorpion Therapeutics on developing and potentially commercializing two of the biotech’s preclinical lung cancer candidates. Read Full Article on Fierce Biotech>>

// Legal & Regulatory

Novartis’ Sandoz must cough up $39M after losing patent fight with Allergan and Duke University
April 4, 2023 / Sandoz / Allergan / Duke University / Patent Infringement – Less than a week after Allergan and Duke University dropped their allegation that Novartis’ Sandoz willfully infringed Duke’s patent for eyelash growth serum Latisse (bimatoprost), a federal jury in Colorado has still sided with the plaintiffs, ordering Sandoz to pay $39 million. Read Full Article on Fierce Pharma >>
Vertex, CRISPR finish US filing for gene editing drug approval
April 3, 2023 / Vertex / CRISPR / Gene Editing / Drug Approval – The treatment could become the first marketed medicine based on CRISPR, the landmark gene editing technology that won a Nobel Prize in 2020. Last September, the FDA allowed Vertex and CRISPR to begin a rolling approval application after clinical testing showed treatment could alleviate the most serious symptoms of both sickle cell disease and beta thalassemia. Read Full Article on Biopharma Drive >>
After Johnson & Johnson loses again in bankruptcy case, it’s game on for talc lawsuits
April 3, 2023 / Johnson & Johnson / Supreme Court / Talc Litigation – After Johnson & Johnson’s initial victory in its attempt to resolve talc lawsuits through a bankruptcy ploy, little has gone the way of the pharma giant. Read on Fierce Pharma >>
AstraZeneca to face tough FDA scrutiny with Imfinzi-Lynparza combo in ovarian cancer: analyst
April 6, 2023 / U.S. FDA / AstraZeneca / PD-1/L1 / PARP Inhinitors – Drugmakers often dream about being the sole player in a therapeutic area. But for AstraZeneca, the lack of rival success stories may mean increased regulatory scrutiny for its new treatment proposal for ovarian cancer. Read on Fierce Pharma >>
5 FDA decisions to watch in the second quarter
April 3, 2023 / FDA / Gene Therapy / ALS Drug / Duchenne Muscular Dystrophy / Vaccines – Over the next three months, the Food and Drug Administration could approve the first vaccines for an elusive virus, the first gene therapy for a deadly neuromuscular disorder and a new treatment for a genetic form of ALS. Read on Biopharma Dive >>

// Research & Development

Masimo receives FDA De Novo clearance for opioid overdose alert system
April 3, 2023 / Masimo / FDA / Novo / Opioid – The monitoring system aims to prevent overdose by alerting family members or caregivers when a patient is experiencing opioid-induced respiratory depression, or slowed or stopped breathing that can be fatal. Read Full Article on Mobi Health News >>
Pardes plans descent from COVID-19 antiviral flight path as lead candidate fails phase 2
April 3, 2023 / Padres Bioscience / Covid-19 / Coronavirus / Drug Development – Pardes Biosciences, launched in 2020 to find treatments in the height of the pandemic, will seek strategic alternatives after its antiviral for COVID-19 failed to clear the virus during a phase 2 trial. Read Full Article on Fierce Biotech >>
Takeda opens 4th front in assault on celiac, tapping Innate to develop antibody-drug conjugates
April 3, 2023 / Takeda / Innate Pharma / Celiac Disease / Antibody-drug Conjugates – Takeda really wants to land a hit on celiac disease. Not content with having just three pipeline prospects, the Japanese drugmaker has partnered with Innate Pharma to attack the disease with another modality: antibody-drug conjugates (ADCs). Read Full Article on Fierce Biotech >>
AstraZeneca’s Imfinzi/Lynparza Combo Boosts Survival in Ovarian Cancer
April 5, 2023 / AstraZeneca / Ovarian Cancer / Cancer – The combination treatment of AstraZeneca’s Imfinzi (durvalumab) and Lynparza (olaparib) met its primary endpoint in the Phase III DUO-O trial in advanced high-grade epithelial ovarian cancer, according to an interim analysis of the study released Wednesday. Read Full Article on BioSpace >>
Cardiovascular Systems, Inc. Completes Enrollment of ECLIPSE Clinical Trial
April 3, 2023 / Cardiovascular / Clinical Trials / Medical Devices- ECLIPSE is a prospective, multi-center, randomized clinical trial of approximately 2,000 subjects with severely calcified coronary lesions in the United States. Half of the participants received orbital atherectomy prior to drug-eluting stent implantation, while the other half received conventional angioplasty, including specialty balloons, followed by DES implantation. Read Full Article on Biospace >>

// Politics

Anti-Vaccine Activist Robert F. Kennedy Jr. to Challenge Biden
April 5, 2023 / Biden / Robert F. Kennedy Jr. / Anti-Vaccine – Robert F. Kennedy Jr., a scion of one of America’s foremost political dynasties who has emerged as a prominent anti-vaccine activist in recent years, will challenge Joe Biden for president in 2024. Read Full Article on Bloomberg News >>
Criminal charges against pharmas over opioid crisis would result only in small fines, Ottawa says
April 2, 2023 / Opioid Crisis / Overdose – The federal government says it hasn’t closed the door on pursuing criminal charges against pharmaceutical companies over their alleged involvement in the opioid crisis — but such charges would result only in minimal fines. Read Full Article on CBC >>
Biopharma industry lobbies for tax breaks related to US-based manufacturing
March 21, 2023 / PhRMA / Joe Biden / Biomanufacturing / API – The business-friendly tax reform enacted in 2017, under the watch of former President Donald Trump, allowed some of the pharma industry’s top companies to slash much of their tax burden. Read Full Article on Fierce Pharma >>
On COVID treatments, it’s Big Pharma vs. everyone else
April 6, 2023 / Covid-19 / Big Pharma / U.S. Trade Commission – World-class Kabuki theatre took the stage at the U.S. International Trade Commission (USITC) last week. Big Pharma interests raged en masse: Death and misery would befall us all if the U.S. government supports temporarily waiving intellectual property rules so people in poor countries can also access COVID-19 tests and treatments. Read Full Article on The Hill >>
U.S. Sen. Baldwin: Introduces legislation to lower drug costs and hold big pharma accountable for price hikesApril 4, 2023 / Lower Drug Cost / Big Pharma / U.S. Senate – U.S. Senator Tammy Baldwin (D-WI) introduced two bills to lower prescription drug costs and increase access to life-saving medications for Wisconsin families. The Lower Drug Costs for Families Act would punish big drug companies for raising prescription drug prices faster than the rate of inflation and the Ensuring Timely Access to Generics Act would tackle sky-high prescription drug costs by increasing competition for generic drugs. Read Full Article on Wis Politics >>