Sanders Suffers Chest Pain, Gets Two Stents

Sen. Bernie Sanders (I-Vt.), a candidate for the Democratic presidential nomination, underwent a cardiac stenting procedure after experiencing chest pains during a campaign event on Tuesday, media outlets are reporting.
“During a campaign event yesterday evening, Sen. Sanders experienced some chest discomfort. Following medical evaluation and testing he was found to have a blockage in one artery and two stents were successfully inserted,” said Sanders’ senior adviser Jeff Weaver on Wednesday in a statement, according to ABC News.

Sanders, 78, has canceled his campaign events and will be resting for the next several days, the campaign said, adding that it will provide updates as needed.
Shortly after announcing his presidential campaign in February, Sanders appeared on the campaign trail with a bandage on his head after being treated at a walk-in clinic for a minor injury while campaigning in South Carolina in mid-March, the story noted. Sanders cut his head in the shower, according to the Associated Press, and after receiving a half-dozen stitches, the senator was given a “clean bill of health.”
https://www.medpagetoday.com/washington-watch/electioncoverage/82523

Trump administration to modernize flu vaccines via government buying power

The U.S. government is laying plans to harness its buying power and applied research capabilities to pull influenza vaccine development and manufacturing into the 21st century. The goals are to enhance protection against seasonal flu, and in the process create infrastructure that could provide rapid, effective responses to pandemic strains.

An Executive Order (EO) on modernizing influenza vaccines signed by President Donald Trump on September 19, and a Council of Economic Advisers (CEA) report released with it, outline the public health, national security and economic imperatives to change the way flu vaccines are manufactured.

Based on existing vaccine manufacturing capabilities, a virulent influenza pandemic could affect millions of Americans and “high rates of illness, missed work, hospitalizations, and deaths” could disrupt the defense and security functions and inflict trillions of dollars in costs on the U.S. economy, the CEA concluded.

“We know of no other virus that spreads as quickly and causes as much death as a pandemic influenza virus,” Rick Bright, HHS deputy assistant secretary for preparedness and response and director of the Biomedical Advances Research and Development Authority (BARDA), told BioCentury.

Bright, the EO and the CEA report all point to the same problem: over-reliance on a 70 year-old manufacturing process that incubates flu viruses in chicken eggs and that cannot produce vaccines quickly enough to blunt a pandemic.

https://www.biocentury.com/biocentury/politics-policy-law/2019-09-27/trump-administration-wants-use-government-buying-power-

Three new IPO filings broaden fall queue

A trio of biotechs filed for NASDAQ listings late Monday, with Phathom, 4D Molecular Therapeutics and Cabaletta each proposing to raise up to $100 million. A fourth, Vir, set terms for an IPO that could price as soon as this week.

The filings fatten a queue that is growing again following a late-summer lull. “We’re seeing more IPOs,” WBB Securities’ Steve Brozak told BioCentury. “People are now rushing to get money” (see “Fall IPO Flurry”).

Frazier Healthcare Ventures and Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) launched Phathom Pharmaceuticals Inc. in May to seek regional approval of gastrointestinal drug vonoprazan, to which it holds a license from Takeda in the U.S., EU and Canada. The company intends to start Phase III trials this quarter of the small molecule potassium-competitive acid blocker to treat erosive esophagitis and Helicobacter pylori infection. The drug is approved in nine countries, and generated more than $500 million in 2018 net sales in Japan (see “Phathom Launches With $90M”).

Phathom’s chairman is former Takeda CMO and CSO Tachi Yamada. Its CEO, David Socks, is a venture partner at Frazier; he intends to relinquish the CEO position to Phathom director Terrie Curran once Bristol-Myers Squibb Co. (NYSE:BMY) closes its acquisition of Celgene Corp. (NASDAQ:CELG), where she is president of the global immunology and inflammation franchise. Socks will then become Phathom’s interim CFO.

Frazier holds 41.1% of Phathom’s equity, while Socks and Yamada hold 14.2% each and Takeda 9.1%. Underwriters on the deal are Goldman Sachs, Jefferies, Evercore and Needham.

4D Molecular Therapeutics Inc. (4DMT) is developing a pipeline of gene therapies based on next-generation adeno-associated viral (AAV) vectors, including three scheduled to enter the clinic next year. Of those, Roche (SIX:ROG; OTCQX:RHHBY) holds rights to a treatment for choroideremia and has an option to another to treat X-linked retinitis pigmentosa; 4DMT’s program for cystic fibrosis is unpartnered.

4DMT has raised $108.6 million to date, including a $90 million series B round led by Viking Global Investors in September 2018. Viking is its largest outside shareholder with 16%, the same size as the stakes of Chairman and CEO David Kim and co-founding Chief Scientific Adviser David Schaffer, while Pfizer Inc. (NYSE:PFE) holds 11.8%. Underwriters are Goldman Sachs, Evercore, William Blair and Chardan (see “4D Raises $90M”).

Cabaletta Bio Inc.’s pipeline consists of chimeric autoantibody receptor (CAAR)-mediated cell therapies, which are autologous T cells that express an autoantigen to treat B cell-mediated autoimmune diseases. The company intends to begin its first clinical study next year of DSG3-CAART to treat pemphigus vulgaris (see “CAAR Ts For Autoimmunity”).

The company’s top three shareholders are 5AM Ventures, Adage Capital Management and Baker Bros. Advisors, each with about 19%. Cabaletta has raised $86.4 million to date, including $50 million in a series B round announced in early January. Morgan Stanley, Cowen and Evercore are underwriters.

Cabaletta’s President and CEO, Steven Nichtberger, teaches a class in biotech company formation at the Wharton School at the University of Pennsylvania. He established the company with scientific co-founders Aimee Payne and Michael Milone, who are both Penn professors.

Vir Biotechnology Inc. proposed to sell 7.1 million shares at $20-$22. At the $21 midpoint, a sale of that many shares would raise $150 million at a postmoney valuation of $2.3 billion. Underwriters are Goldman Sachs, J.P. Morgan, Cowen and Barclays

Three-year-old Vir, which is led by led by former Biogen Inc. and Exelixis Inc. CEO George Scangos, is taking an immunological approach to combating infectious diseases such as HBV, influenza, HIV and tuberculosis (see “Vir Plots IPO”).

https://www.biocentury.com/bc-extra/financial-news/2019-10-01/three-new-ipo-filings-broaden-fall-queue

One-fourth of doctors not confident they can safely get patients off opioids

While 86% of physicians agreed that helping people get off of opioids is a fundamental part of stopping the country’s epidemic, a quarter of them say they aren’t confident they can safely get patients off the addictive drugs.
Some 80% of physicians say there is a lack of education about how to help their patients stop taking opioid painkillers, according to a new national survey from US WorldMeds that asked both doctors and consumers about barriers to ending the opioid crisis.

Both agreed a lack of education around how to discontinue opioids is a huge barrier to the epidemic which the Centers for Disease Control and Prevention (CDC) says has resulted in the deaths of more than 200,000 Americans from prescription opioid overdoses since the addiction crisis began in the late 1990s.
According to the survey, 86% of physicians and 88% of the American public agree that helping people get off of opioids should be a fundamental part of addressing America’s opioid crisis. However, nearly a quarter of physicians are not confident they can safely get patients off of opioids.
Some 76% of physicians say that fear of opioid withdrawal is keeping patients from getting off of opioids.

The survey conducted in June included 500 physicians and 1,100 U.S. adults. “Physicians and patients are overwhelmingly asking for more education around stopping opioids,” said P. Breckinridge Jones, CEO and founder of US WorldMeds, a specialty pharmaceutical company based in Louisville, Kentucky.
Both the CDC and the Food and Drug Administration earlier this year warned prescribers that abruptly cutting off high-dose patients or tapering their doses of opioids too rapidly could cause withdrawal and even suicide.

https://www.fiercehealthcare.com/practices/one-fourth-doctors-not-confident-they-can-safely-get-patients-off-opioids

GlaxoSmithKline and Innoviva look for new Trelegy use

GlaxoSmithKline (NYSE:GSK) and Innoviva (NASDAQ:INVA) announce the filing of a supplemental new drug application to the FDA for an additional indication for the use of Trelegy Ellipta for asthma in adults.

The companies note Trelegy Ellipta was approved in the U.S. in 2017 for the treatment of patients with chronic obstructive pulmonary disease.

Source: Press Release

https://seekingalpha.com/news/3503328-glaxosmithkline-innoviva-look-new-trelegy-use

Sarepta competitor files with FDA for Duchenne drug

Sarepta Therapeutics (NASDAQ:SRPT) -3% pre-market after Japanese drugmaker NS Pharma said it filed with the U.S. Food and Drug Administration to seek approval for its new drug to treat Duchenne muscular dystrophy.

If approved, the NS Pharma drug would be the first treatment for children born with Duchenne caused by a mutation in the DNA.

In August, the FDA raised concerns about SRPT’s New Drug Application seeking accelerated approval of golodirsen injection for treatment of DMD.

https://seekingalpha.com/news/3503331-sarepta-competitor-files-fda-duchenne-drug

Veeva acquires Crossix, pairing doctor, patient data and marketing services

Veeva Systems is buying Crossix Solutions with an eye to integrating the Veeva healthcare professional (HCP) cloud software services with the more patient-centric Crossix data and analytics.
Under the $430 million cash deal, Crossix will remain an independent unit inside Veeva called Veeva Crossix and will continue to be run by Crossix CEO Asaf Evenhaim.
Crossix’s data—both health and non-health—come from 300 million patients in the U.S. and include prescription, OTC, clinical, claims and hospital data to help inform pharma marketing initiatives. Crossix said more than 200 pharma brands use its services.

Paul Shawah, Veeva senior vice president of commercial strategy, said the deal makes sense, as Veeva and Crossix grew up together in adjacent markets—with life science professionals for Veeva building communication channels for field reps, and with patients for Crossix building out data, analytics and privacy for pharma marketers.
He said while it’s still early, the potential and power is in combining the two.
“What we’ll be able to do is link patient data to healthcare professionals, so you start to better target HCPs based on the patients that they actually treat,” he said.
That leads to the potential for integration or cross-sharing data to do things like match patient activity data with patient data and outcomes, study cause-and-effect relationships and enhance custom reference data to better target and serve patients.

Evenhaim agreed and offered an example of how the integration can boost both sides’ offerings.
“When marketing managers, for example, look to optimize a digital media camp, they can look at how the advertising is doing in terms of getting new patient starts, but also look at how much of that is prescribed by physicians the field force recently called on versus physicians that have not been called on,” he said. “That kind of insight, that ability to integrate the patient and the HCP and sales and marketing, is pretty powerful.”
https://www.fiercepharma.com/marketing/veeva-acquires-patient-data-and-analytics-specialist-crossix-pairing-hcp-and-patient-data