// Biotech and Pharma Therapeutics

The Kidney Medicine’: Bayer Touts Kerendia’s Blockbuster Potential As Its Pharma Group Swings Back To Growth
August 5, 2021 Type 2 Diabetes / Cardiovascular / Pharma Among the potential blockbusters that could save the day for Bayer when top-selling meds Eylea and Xarelto fall off the patent cliff, the German company is touting one simply as “the kidney medicine.” That’s the title Bayer pharma chief Stefan Oelrich endowed on newly approved Kerendia, which the company has projected could reach over €1 billion in peak sales. Approved last month, Kerendia carries a broad label to reduce the risk of kidney function decline, end-stage kidney disease, cardiovascular death, nonfatal heart attack and hospitalization for heart failure in patients with chronic kidney disease associated with Type 2 diabetes. Read Full Article on Fierce Pharma >>
Bayer’s Investigational P2X3 Antagonist Meets Primary Efficacy Endpoint And Shows Favorable Safety And Tolerability Profile
Augest 3, 2021 Refractory Chronic Cough / Neuropathy  Bayer today announced positive results from the Phase IIb clinical trial evaluating the efficacy and safety of its investigational orally administered, potent and selective P2X3 receptor antagonist eliapixant (BAY1817080) in patients with refractory chronic cough. The primary efficacy outcome was met showing a statistically significant improvement in 24-hour cough counts per hour (average hourly cough frequency based on 24-hour sound recordings) over placebo after 12 weeks of treatment. The data showed a favorable safety and tolerability profile. Read Full Article on Pipeline Review >>
First half of 2021: Boehringer Ingelheim makes fundamental progress in research and development
August 3, 2021 R&D / Empagliflozin / HFpEF In July, Boehringer Ingelheim reported a breakthrough in the treatment of heart failure with empagliflozin (marketed as JARDIANCE®). More than 60 million patients worldwide suffer from this disease, approximately half of them from heart failure with preserved ejection fraction (HFpEF). Heart failure with left ventricular preserved ejection fraction occurs when the left ventricle of the heart is unable to fill properly, resulting in less blood being pumped to the body. A recent trial showed a significantly lower risk with empagliflozin of hospitalization for heart failure or cardiovascular death in adult patients with HFpEF. Read Full Article on Business Wire >>
Living Biotherapeutics Explore New Niches
August 2, 2021 Biotherapeutics / CNS / Oncology In the not-too-distant future, diseases of the central nervous system (CNS) may be treated by therapies derived from living gut bacteria. Such therapies are in development at 4D pharma, a company that is also working toward more immediate goals, such as microbiome therapeutics for autoimmune diseases, respiratory diseases, and forms of cancer. The most immediate applications are, of course, in gastrointestinal diseases. Read Full Article on GEN & Biotechnology News >>
Metformin Hydrochloride API Market: Rise in Prevalence of Diabetes to Drive Market
August 03, 2021 Diabetes / Metformin According to the report, the global metformin hydrochloride API market was valued at ~US$ 300 Mn in 2020 and is projected to expand at a CAGR of ~5% from 2021 to 2031. Metformin hydrochloride is primarily used in the treatment of diabetes. The prevalence of diabetes is expected to increase across the world due to change in lifestyle and factors such as malnutrition and genetic mutations. According to government and private organizations operating in the diabetes industry, diabetes is considered one of the top fatal diseases globally. Read Full Article on BioSpace >>

// 4th Industrial Revolution

Insulin-Producing Implants Are Being Developed To Control Type 1 Diabetes
August 4, 2021 4IR / Type 1 Diabetes / 3D Printing Scientists are using 3D printing technology and smart biomaterials to create an insulin-producing implant for people with Type 1 diabetes. Bioengineers from Rice University, in Houston, Texas, will use insulin-producing beta cells made from human stem cells to create an implant that senses and regulates blood glucose levels by responding with the correct amount of insulin at a given time. Read Full Article on Health Europa >>
Using Conductive Nanomaterials to Combat Cardiovascular Disease
August 3, 2021 4IR / Nanomaterials / Cardiovascular Heart attacks arising from the obstruction of arteries blocking blood flow are one of the major risks of cardiovascular disease. The build-up of scar tissue in the heart can severely reduce the efficiency of the organ, which itself is life-threatening. Current medical approaches to returning function to the heart and limiting the effects of scar tissue growth exist but carry limitations. Not in the least the fact that these interventions are usually just short-term solutions. A new research paper published in the journal Mircomachines¹ suggests that more long-term solutions to the after-effects of heart attacks  —  more formally known as myocardial infarction  —  could be delivered by nanotech tissues which can mimic cardiac tissue. Read Full Article on AZO Materials >>
A Pivotal Moment for CRISPR in the Gene Editing Journey
August 4, 2021 4IR / CRISPR / Genetic Data After 20 years of toiling and dreaming, the field of genome editing has arrived. Since the 1990s, it has been arriving slowly, out of the limelight. That all changed in 2012 when Jennifer Doudna and Emmanuelle Charpentier pioneered CRISPR/Cas9 – the molecular toolkit that allows scientists to change the genetic code of living organisms. Since then, companies like Editas Medicine, CRISPR Therapeutics, Intellia Therapeutics, and Vertex Pharmaceuticals, have been working to turn the technology into actionable therapeutics. Read Full Article on BioSpace >>
Digital Health Apps Balloon To More Than 350,000 Available On The Market, According To IQVIA Report
August 4, 2021 4IR / Digital Health Apps / IQVIA The number of consumer digital health apps ballooned last year, with more than 90,000 new ones introduced in 2020, according to a new report by the IQVIA Institute for Human Data Science on digital health trends. The report found there are now more than 350,000 digital health apps available to consumers. While many are geared toward general wellness or fitness, and some are middling in quality, specific disease management apps are increasing in number. Apps that focus on managing specific diseases or health conditions now make up 47% of apps, compared with 28% in 2015. Mental health, diabetes and cardiovascular disease-related apps make up almost half of condition-specific apps. Read Full Article on Mobile Health News >>
SoftBank’s Pharma AI Bet Has Long Odds
August 4, 2021 4IR / Artificial Intelligence / Drug Development SoftBank (9984.T) may be hunting for tech treasure in pharma colossus Roche (ROG.S). The Japanese investor has amassed a $5 billion stake in the $342 billion Swiss drugmaker, according to Bloomberg. Its appeal lies in Roche’s increasing use of sophisticated data analysis to find drugs in its Genentech unit, Bloomberg says. Read Full Article on Reuters >>
From Theory to Real-World Practice: Clinical Integration of Digital Therapeutics
August 2, 2021 4IR / DTx / Mental Health Digital therapeutics (DTx) is a new category of medicine that refers to treatments delivered directly to patients via software or apps. The scope of DTx encompasses treatment, management, and prevention of a broad spectrum of diseases and disorders. As such, DTx are part of a larger ecosystem of digital health technologies that provides support for patients, clinicians, and medical institutions. These technologies include patient- and clinician-platforms, as well as the unseen operational components. Read Full Article on Psychiatric Times >>

// Business & Markets

Bayer Inks A $1.5 Billion Deal For A Biotech With A Proprietary Drug Discovery Platform
August 5, 2021 Deals / Oncology / Immunology In a bid to quickly broaden its drug discovery abilities, Bayer (BAYRY) has reached a deal to acquire Vividion Therapeutics for $1.5 billion, the third time in two years the company has bought a small biotech with proprietary technology for uncovering medicines. Unlike the two earlier acquisitions, which gave Bayer entree to potential gene and cell therapies, the focus of this latest acquisition is primarily on oncology and immunology, although that can be expanded to other therapeutic areas. Vividion developed a platform for chemoproteomics, which is an approach to understanding interactions between small molecule compounds and proteins in biological systems. Read Full Article on STATNews >>
Are You Missing Out On A Sudden $85 Billion Biotech Stock Rally?
August 5, 2021 Biotech Stocks Information technology stocks in the S&P 500 get most of the attention. But now biotechnology is stealing the spotlight. The $11 billion-in-assets iShares Biotechnology ETF (IBB) suddenly shot up in the third quarter, 5.2% so far. That tops the 4.4% rise during the quarter by the Technology Select Sector SPDR ETF (XLK). And it leaves the S&P 500’s 2.6% rise this quarter in the dust, too. Read Full Article on Investor’s Business Daily >>
EXCLUSIVE Sanofi Offers To Buy U.S. Biotech, mRNA Partner Translate Bio-Sources
August 3, 2021 Deal / mRNA / Vaccines Sanofi (SASY.PA) has offered to buy U.S. biotech company Translate Bio (TBIO.O), two sources familiar with the situation said on Monday, as the French drugmaker bets on next-generation mRNA technology after setbacks in the COVID-19 vaccine race. Shares in the New York-listed biotech company soared more than 70% to above $50 in extended trading, building on the big gains in the stock as investors have piled in to the sector amid a rush to develop vaccines and treatments to tame the pandemic which has killed 4.3 million and roiled the global economy. Read Full Article on Reuters >>
How Bayer Lured a Biotech Away From an IPO and Into a Buyout
August 5, 2021 Deal / IPO / Oncology In what has become a common move by large pharmaceutical companies attempting to revitalize their drug research, German healthcare conglomerate Bayer has acquired a small biotechnology company developing drugs for cancer and immune diseases. Bayer on Thursday said it will pay $1.5 billion upfront for the company, Vividion Therapeutics, which has disclosed several drug candidates it’s preparing for clinical tests. Vividion could receive as much as $500 million more, should it hit certain development milestones. Read Full Article on BIOPHARMA DIVE >>
Demand For Diabetes And Obesity Care Boosts Novo Nordisk Profit
August 5, 2021 Diabetes / GLP-1 / Obesity Danish pharma company Novo Nordisk reported a 10% rise in first-half net profit on Wednesday as sales within diabetes and obesity care grew. In its earnings release, the company said sales were up 13% at constant exchange rates, clocking in at DKr56.9bn Danish kroner ($9.05bn). Sales for the company’s portfolio of GLP-1 diabetes treatments, which includes Ozempic and its oral counterpart Rybelsus, leapt 30%. Read Full Article on Capital >>
Demand For Novo Nordisk’s New Weight-Loss Drug Wegovy Outstripped Early Supply, Analysts Say
August 4, 2021 Diabetes / GLP-1 / Obesity Novo Nordisk’s GLP-1 empire is on the ascent, courtesy of its diabetes stalwarts Ozempic and Rybelsus, plus its newly-approved obesity drug Wegovy. With momentum building—and facing “substantial” demand for its new weight loss med—the Danish drugmaker is dialing up its performance forecast for the year, CEO Lars Fruergaard Jørgensen said Wednesday. During the first six months of 2021, Novo’s diabetes and obesity sales grew 13% at constant exchange rates, clocking in at 56.9 billion Danish kroner ($9.05 billion), the company said in an earnings release. Sales for the company’s GLP-1 arsenal, which includes Ozempic and its oral counterpart Rybelsus, leapt 30% at constant currencies. Read Full Article on Fierce Pharma >>

// Legal & Regulatory

HEALTH CARE BRIEFING: Pharma Could Face Billions in Waste Fines
August 5, 2021 US Senate / Medicare / Infrastructure Drug manufacturers Takeda Pharmaceutical and Roche could each be forced to repay the government $100 million annually for wasted medicines under the bipartisan Senate infrastructure deal. The $550 billion legislation, which the Senate is debating this week, would require companies to refund Medicare when doctors throw away drugs, a move meant to push some drugmakers to stop overpacking single-use containers. The funds would offset part of the bill’s spending on roads and bridges. Read Full Article on Bloomberg Government >>
J&J Notches A Win In $50M Talc Lawsuit, But Tens Of Thousands Still Pending
August 2, 2021 Lawsuits / FDA / Cancer Johnson & Johnson notched a win Friday, with a $50 million talc lawsuit rejected in Illinois—however, tens of thousands of cases are still pending. J&J recently reported 34,600 talc-related lawsuits have now been filed which is up from just over 20,000 last year. The Illinois case, filed in 2018 by relatives on behalf of Elizabeth Driscoll who died from ovarian cancer in 2016, sought up to $50 million in damages. The three-week jury trial found in favor of J&J, ruling the pharma giant was not liable. Read Full Article on Fierce Pharma >>
Flexible Work Could Boost Diversity for In-House Law Departments
July 30, 2021 Legal / Remote Work / Hybrid Schedule Celia Catlett might still be the general counsel of Texas Roadhouse, Inc., if flexible work arrangements had been as common in 2019 as they are now. “My kids were getting older, my husband was traveling a ton, and our family life reached a breaking point,” Catlett said. “As often happens in families, mom is the one who ducks out of the career.” Had remote or flexible work arrangements had been an acceptable option, Catlett said she probably would have stayed in the legal industry a little longer instead of retiring in August 2019 at the age of 43, months before the Covid-19 pandemic forced a shift for many lawyers to working from home. Read Full Article on Bloomberg Law >>
San Mateo County Files Lawsuit Alleging McKinsey and Company Helped Push Local Opioid Sales
August 4, 2021 Opioids / Lawsuits San Mateo County has filed a lawsuit against McKinsey & Company, alleging that the consulting firm helped push opioid sales in the county. Cotchett, Pitre & McCarthy LLP, the law firm representing the county, alleges that McKinsey helped opioid manufacturers increase drug sales by serving as marketing advisor to companies like Purdue Pharma. Purdue Pharma makes OxyContin, a prescription pain medication commonly involved in opioid overdose deaths. Read Full Article on CBS Local >>
Common Fraud in the Pharmaceutical Industry Reported by Whistleblowers
August 5, 2021 Fraud / Marketing / Price Reporting The pharmaceutical industry is regularly found to be engaging in fraud of many types and it appears as though each year, the number of pharmaceutical fraud is on the rise. Each year big pharma giants end up spending billions of dollars in paying for fraud, misrepresentation of data and other such corruption allegations leveled out against them. Read Full Article on CRI Group >>

// Research & Development

Beigene Lays Plans For ‘Flagship’ Biologics Plant And R&D Center In New Jersey
Augest 3, 2021 Oncology / Manufacturing / R&D BeiGene has designs on a flagship manufacturing and clinical R&D center in the U.S., and it’s clinched a deal for roughly 42 acres with more than one million square feet of developable land to see its mission through. The new plant, planned for Hopewell, New Jersey, will come equipped to handle commercial-scale biologics manufacturing and clinical R&D, plus include office space, Michael Garvey, Global Head of Technical Operations at BeiGene, told Fierce Pharma. Read Full Article on Fierce Pharma >>
Humanized Mouse Model Market Report | How Has COVID-19 Affected The Market?
August 5, 2021 In Vivo / Humanized Mouse Model Market TMR Research speaks on the core issues and characteristics of the global humanized mouse model market, along with its nuances and opportunities of growth over the coming years, in “Humanized Mouse Model Market – Global Industry Analysis, Size, Share, Trends, Analysis, Growth, and Forecast 2017 – 2025.” Read Full Article on BioSpace >>
Innovators in Pharma Sectors See Potential, Promise in Providing Improved Treatments
August 5, 2021 Hypertension / Innovation / API A leading cause of death in the United States for men and women of most racial and ethnic groups, heart disease is a pervasive health challenge that destroys lives. The Center for Disease Control and Prevention (CDC) reports that one person dies every 36 seconds from cardiovascular disease. Treating the disease, as well as the conditions related to it such as high blood pressure, or hypertension, is a top priority for those in the medical space, and innovative companies are looking for ways to provide even more effective treatments. Read Full Article on Cision >>
Why Data Management Is Critical For Faster Drug Development
August 3, 2021 Data Management / Drug Development / R&D For every 5,000 drug candidates, only one results in a commercial product, according to the Pharmaceutical Research and Manufacturers of America. The Journal of the American Medical Association (JAMA) found that “the estimated median capitalized research and development cost per product was $985 million.” Clinical researchers at leading pharmaceutical companies can easily generate tens of terabytes of data every day through scientific experiments. This treasure trove of unstructured data defines years of research and insights, and it needs to be accessible, manageable and visible. To put this in perspective, 10TB of data is roughly 1 million phone books worth of data. Read Full Article on Forbes >>

// Politics

Exclusive: U.S. Developing Plan to Require Foreign Visitors to be Vaccinated, Official Says
August 5, 2021 Travel / COVID-19 / Vaccination The Biden administration is developing a plan to require nearly all foreign visitors to the United States to be fully vaccinated against COVID-19 as part of eventually lifting travel restrictions that bar much of the world from entering the United States, a White House official told Reuters on Wednesday. The White House wants to re-open travel, which would boost business for the airlines and tourism industry, but is not ready to immediately lift restrictions because of the rising COVID-19 case load and highly transmissible COVID-19 Delta variant, the official said. Read Full Reuters >>
As Delta Wreaks Havoc, Biden Faces Growing Pressure To Force Big Pharma To Share Vaccine Recipes
August 2, 2021 Intellectual Property / Vaccines With a proposed patent waiver for coronavirus vaccines still mired in fruitless talks at the World Trade Organization, U.S. President Biden is facing growing calls to use his legal authority to force pharmaceutical giants to share their vaccine recipes as governments around the world race to combat the fast-spreading Delta variant. The U.S. government currently owns the patent for critical spike-protein technology developed by the National Institutes of Health. That technology, which helps trigger an immune response against the coronavirus, has been utilized by at least five companies in the development of vaccines, including Moderna, Pfizer, and Johnson & Johnson. Read Full Article on Salon >>
Biden Administration to Support Resilience of US Pharma Supply Chain
August 2, 2021 Supply Chain / Pharma / API Production The Biden-Harris Administration have announced that it will take immediate action to shore up the US’s pharmaceutical supply chain by establishing a consortium to prioritise onshoring of essential medicine production and financially supporting the domestic production of active pharmaceutical ingredients (APIs). In February 2021, President Biden signed E.O. 14017, directing a whole-of-government approach to assessing vulnerabilities in, and strengthening the resilience of, four critical supply chains: semiconductor manufacturing and advanced packaging; large capacity batteries; critical minerals and materials; and pharmaceuticals and APIs. Read Full Article on European Pharmaceutical Review >>
Biden Patent Office Pick Will Shape Fight Over High Drug Prices
July 30, 2021 Drug Pricing / USPTO The path toward lower drug prices could hinge on who President Joe Biden picks as the next director of the U.S. Patent and Trademark Office. Generic drug groups are pushing for a PTO chief who will make it easier to invalidate patents they find as obstacles to bringing lower-cost medicines to the market. Proponents of strong intellectual property protections believe they are the gateway to innovation, and want a director like Andrei Iancu who will take steps to ensure that inventors aren’t easily stripped of their rights. Read Full Article on Bloomberg Law >>