// Biotech and Pharma Therapeutics
J&J plans to split into two companies, separating consumer products and pharmaceutical businesses
November 12, 2021 / J&J / Consumer products / Pharma / Healthcare
The separation will sheer off its household products unit, maker of Band-Aid bandages, Aveeno and Neutrogena skin care products, and Listerine, from its riskier, but faster-growing division that makes and sells prescription drugs and medical devices, including its Covid-19 vaccine.
EU pharmaceutical giants run old, vulnerable apps and fail to use encryption in login forms
November 11, 2021 / Europe / Cyberattacks / Healthcare / Pharma
New research into the security posture of Europe’s top pharmaceutical giants has revealed concerning levels of vulnerabilities and weak spots in web applications.
80% of EU Pharmaceutical Businesses Are ‘Critically Exposed’ to Cyberattacks: Report
November 12, 2021 / EU Pharma / Cyberattacks
The leading pharmaceutical companies in Europe were found out to be “extremely exposed” to a high risk of cyberattacks, according to the latest research. Healthcare firms have struggled a lot because of alarming levels of vulnerabilities in their systems.
Pharma Price Controls aren’t the simple answer they promise to be
November 10, 2021 / Pharma / Drug Price / Price Control
Despite amazing innovation, the amount Americans spend on cancer medications doubled from $15.9 billion to $37.8 billion from 2016-2021. Individual treatments have seen price hikes from $4,500 to more than $10,000 per month of treatment (a rate much higher than inflation), and of the 13 treatments approved in the last five years, 12 cost over $100,000 per year.
100 years of insulin: a technical success but an access failure
November 13, 2021 / Insulin / Diabeties
A Review describes the scale of the problem when it comes to insulin access in low-income and middle-income countries. There is a paucity of data—fewer than half of countries in central and east Asia and western sub-Saharan Africa have the necessary policies and registries to account accurately for the numbers and needs of patients with diabetes. Globally, an estimated 76% of children with type 1 diabetes are unable to stay within the recommended glycaemic ranges, putting them at risk of life-threatening short-term and long-term complications.
// 4th Industrial Revolution
AI hiring levels in the pharmaceutical industry dropped in September 2021
November 11, 2021 / AI / Pharma / Hiring
The proportion of pharmaceutical companies hiring for artificial intelligence related positions dropped in September 2021, with 30.4% of the companies included in our analysis recruiting for at least one such position.
New AI Collaborations Reflect Rapid Growth in Pharmaceutical Industry
November 16, 2021 / AI / Pharma
Artificial intelligence is becoming the darling of the biopharma industry after years of testing and discussion. As the capabilities have been proven, AI is establishing a firm foothold in the key areas of R&D, drug development, clinical trials and, to some extent, patient-facing products.
Revealed: the pharma companies leading the way in artificial intelligence
November 12, 2021 / Pharma / AI / J&J / Norvartis
Novartis and Johnson & Johnson are among the companies best positioned to take advantage of future artificial intelligence disruption in the pharmaceuticals industry, our analysis shows.
Google launches DeepMind 2, a pharmaceutical hullabaloo
November 5, 2021 / Google / DeepMind2 / Alphabet / Isomorphic Labs
Alphabet (the umbrella corp that owns Google and DeepMind) just launched Isomorphic Labs (IL). According to the new company’s blog, it’s “reimagining the entire drug discovery process from first principles with an AI-first approach.” In other words: The CEO of DeepMind, Demis Hassabis, is going to run a drug-discovery spinoff.
Johnson & Johnson CEO joins Apple’s board of directors
November 10, 2021 / J&J / Apple
It’s not surprising that Apple has tapped Gorsky to be part of its governance team, as the company has been very public about its health and wellness ambitions, including launching a number of health-focused features for iOS and WatchOS over the years.
// Business & Markets
Traders Should Be Stopped Out of Biohaven Pharmaceutical
November 11, 2021 / Biohaven Pharma / Mad Money / Traders
In his first “Executive Decision” segment of Wednesday’s Mad Money program, Jim Cramer spoke with Vald Coric, CEO of Biohaven Pharmaceutical (BHVN), the biotech. Biohaven just announced a global partnership with Pfizer (PFE) to bring its migraine treatment, Nurtec ODT, to patients outside the U.S. Coric said in the deal, Biohaven retains the U.S. rights to Nurtec, but leverages Pfizer’s global presence to commercialize the drug around the globe.
Organon to Acquire Forendo Pharma
November 11, 2021 / Organon / Forendo / Women’s Health
Organon, and Forendo Pharma today announced that the companies have entered into a definitive agreement, under which Organon will acquire Forendo, a clinical-stage drug development company focused on novel treatments in women’s health. Forendo is pioneering the science of intracrinology, addressing disease through a novel, tissue-specific approach.
Investors are betting that Pfizer’s ‘game-changing’ antiviral pill will reduce demand for COVID vaccines
November 8, 2021 / Pfizer / COVID / Vaccine / Antiviral Pill
On Monday, stocks of vaccine makers in Asia fell in the wake of U.S. pharmaceutical giant Pfizer’s announcement that its new antiviral pill called Paxlovid is 89% effective in reducing risk of hospitalization or death from COVID-19.
Blackstone continues biotech push with up to $250M cell therapy investment
November 8, 2021 / Blackstone / Cell Therapy / Biotech
Blackstone first made its biotech ambitions known in October 2018 when it bought Clarus Ventures, a life sciences investment firm with about $2.6 billion under management. Blackstone Life Sciences was formed through that deal, with a goal to, among other things, advance drugs that had been gathering dust on the shelves of pharmaceutical companies.
Teladoc partners to offer virtual-first health plan
November 8, 2021 / Teladoc / Trustmark Health Benefits / Healthcare
Members will pay $0 co-pays for virtual services and preferential cost sharing for in-person services that are referred by Primary360 providers. The virtual-first plan will be available to employers nationwide beginning next year.
// Legal & Regulatory
Celgene Corp. v. Mylan Pharmaceuticals Inc. (Fed. Cir. 2021)
November 10, 2021 / Celgene Corp / Mylan Pharma / New Drug
The question of the proper court for a branded pharmaceutical maker to bring suit against an Abbreviated New Drug Application filer under the Hatch-Waxman Act is surprisingly unsettled seeing as the Act was enacted in 1984. The Federal Circuit brought some measure of clarity to the question recently when it affirmed a District Court dismissal of an ANDA action on improper venue grounds, in Celgene Corp. v. Mylan Pharmaceuticals Inc.
FDA Issues Final and Draft Guidances on Biosimilar Development under BPCIA
November 8, 2021 / FDA / Biosimilar Development / BPCIA
The Final Guidance provides its Answers in final form, having been subject to the notice and comment requirements for FDA Guidances and originally promulgated as Questions and Answers on Biosimilar Development and the BPCI Act (April 2015) and New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2) (December 2018). The Answers are classified into three groups: biosimilarity or interchangeability; provisions related to the requirement to submit a BLA for a “biological product”; and exclusivity.
Johnson & Johnson scores reversal of landmark $465M opioid ruling in Oklahoma
November 9, 2021 / Lawsuit / Litigation / Opioid / AmerisourceBergen
Oklahoma’s Supreme Court overturned a lower court’s $465 million verdict that concluded J&J’s opioid marketing created a public nuisance in the state. In the 5-1 Oklahoma Supreme Court vote, justices found that the state’s public nuisance law doesn’t apply to the allegations presented in the lawsuit from Oklahoma’s former attorney general, Mike Hunter.
Government Legal Battle Looms Over Who Should Take Credit For Moderna Vaccine
November 11, 2021 / Moderna / Vaccine / COVID-19
The U.S. National Institutes of Health is doubling down on its right to be credited on some of Moderna’s key Covid-19 vaccine patents, according to Reuters, setting the stage for a legal battle with the biotech firm that could determine the shot’s future price and availability.
Legal Challenges To OSHA’s Vaccination And Testing Emergency Temporary Standard
November 9, 2021 / OSHA / Vaccine / COVID-19
If you’re aware of the coronavirus pandemic, chances are pretty high you’re also aware that Occupational Safety and Health Administration (OSHA) just announced its COVID-19 Vaccination and Testing Emergency Temporary Standard (Vaccine and Testing ETS). This regulation would require most employers with 100 or more employees to either mandate the coronavirus vaccine for their employees or have them get regularly tested and wear a face-covering in the workplace.
// Research & Development
How Digital Transformation Could Change Research And Development For Pharmaceutical And Beauty Companies
November 12, 2021 / Pharma / R&D
Talking about research and development for the pharmaceutical and cosmetics industries used to conjure up images of scientists isolated in laboratories. Today, digital technology is set to change the field radically; digital factory revenue alone could reach $4.5 billion by 2030, according to ABI Research (via PR Newswire), and pharmaceutical manufacturers could spend $1.2 billion on data analytics by 2030.
Burns Market Expected to Exhibit Dynamic Growth at an Increased CAGR of 1.96% in the 7MM for the Study Period 2018-30, Analyzes DelveInsight
November 8, 2021 / Pipeline / Burns Treatment
DelveInsight’s Burns Market Insights report proffers a detailed comprehension of Burns market size by treatment, epidemiology, emerging therapies, Burns market drivers, market barriers, and ongoing clinical trials. The report also provides an understanding of Burns market share of the individual therapies, current and forecasted Burns market size from 2018 to 2030 segmented into 7MM (the US, EU5 (the UK, Italy, Spain, France, and Germany), and Japan).
Detailed Roche study results muddy another Alzheimer’s hypothesis
November 11, 2021 / Roche / Alzheimer / Swiss Biotech
The drug, developed by AC Immune and licensed to Roche, reduced the rate of cognitive decline by 44% over placebo in a small Phase 2 study of some 270 patients with mild-to-moderate Alzheimer’s. That finding, when it was disclosed in August, propelled shares in AC Immune higher by more than half on hopes it represented an advance for drugs that target an Alzheimer’s-linked protein called tau.
Moderna founder unveils new drug company focused on a different kind of RNA
November 9, 2021 / Moderna / New Drug / RNA
Long before we knew how they did it, human cells had refined the process for making proteins, the microscopic workers needed for pretty much everything our bodies do.
Biogen Says Aduhelm Significantly Lowers Another Top Alzheimer’s Biomarker
November 12, 2021 / Biogen / Alzheimer / Aduhelm
Despite the controversy surrounding the approval of Biogen’s Alzheimer’s drug Aduhelm (aducanumab), the company announced new data that shows the medication reduces amyloid plaque and significantly lowers plasma p-tau181, a biomarker of the hallmark tau tangles in Alzheimer’s disease.
// Politics
Pharmaceutical industry likely to shatter its lobbying record as it works to shape Democrats’ spending bill
November 5, 2021 / Pharma / Spending bill
A years-long battle over prescription drug prices reaches its apex as the industry spends tens of millions to alter the plans.
Congressional Republicans Propose to Abolish America Invents Act (and a Bit More)
November 11, 2021 / Republicans / Invents Act
It being the holiday season in America, it is perhaps appropriate that patent traditionalists get something more than coal in their stocking from Representatives Massie (R-KY), Gohmert (R-TX), Gosar (R-AZ), and McClintock (R-CA) in the form of H.R. 5874, the “Restoring America’s Leadership in Innovation Act of 2021.”
Governor Murphy Signs Legislation Promoting Transparency on the New Jersey Drug Utilization Review Board
November 8, 2021 / Governor Murphy / New
Jersey
Governor Phil Murphy today signed legislation (A-277/S-2035) that requires public members of the New Jersey Drug Utilization Review Board to submit disclosures of financial interests and involvement in pharmaceutical distributors, manufacturers, or benefits managers. The bill continues the Murphy Administration’s efforts to promote transparency and integrity in health care.
Biden Chooses Robert Califf to Lead F.D.A., Despite Drug Industry Ties
November 12, 2021 / Biden / FDA / Clinical Trial
Dr. Robert M. Califf, an academic and clinical trial research who ran the agency in 2016, has also consulted for pharmaceutical companies.
Biden’s Overdose Prevention Plan Faces Social, State Barriers
November 9, 2021 / Covid-19 Pill / Merck & Co / FDA
Merck is now in a race with Pfizer to capture the upside of COVID-19 pills, which could soon play an outsized role in the next phase of the pandemic and beyond.