Skip to main content

Posts

Showing posts from August, 2021

Elizabeth Holmes on Trial Reuters

  SAN JOSE, Calif. (Reuters) - As Theranos founder Elizabeth Holmes’ highly anticipated fraud trial began on Tuesday, the judge overseeing the case quizzed potential jurors about whether they could be fair considering the intense media coverage about the entrepreneur, who has long been a subject of fascination in Silicon Valley. Dozens of prospective jurors crowded in to a small federal courtroom in San Jose, California, wearing masks and sitting one seat apart to protect against COVID-19. Holmes, 37, has pleaded not guilty to defrauding Theranos investors and patients by falsely claiming that the now-defunct blood testing company had developed technology to run a wide range of tests on a single drop of blood. The meteoric rise and spectacular fall of Theranos turned Holmes from a young billionaire into a defendant who could face years in prison if convicted. When asked on Tuesday if they had been exposed to media coverage of the case, more than a third of the potential jurors raised t

Pennsylvania reports increases in gonorrhea and syphilis, Most in 30 years

  The Pennsylvania Department of Health (DOH) issued a health alert Monday concerning increases in the sexually transmitted infections, gonorrhea and syphilis. Concerning gonorrhea, Pennsylvania (exclusive of Philadelphia) reported a 21.83% increase in gonorrhea, from 9,012 cases reported in all of calendar year (CY) 2019 to 10,980 cases reported in CY 2020.  44 out of 66 counties reported an increase. The reported 10,980 cases in CY 2020 represents the highest number of Gonorrhea cases in more than 30 years. Additionally, during CY 2020, Pennsylvania (exclusive of Philadelphia) reported a 2.49% increase in reported Primary and Secondary (P&S) Syphilis, from 522 cases reported in CY 2019 to 535 cases reported in CY 2020. The reported 535 cases reported in CY 2020 represent the highest number of reported P&S cases in approximately 30 years. Individuals under age 30 are accounting for a significant portion of the increases in reported STI cases. In CY 2020 this segment of the pop

Pakistan: More than 1700 XDR Typhoid cases reported in Karachi this year Outbreak news

  The Pakistan National Institute of Health reported an additional 52 extensively drug-resistant (XDR) typhoid fever the week ending Aug. 14 in Karachi, bringing the total cases in 2021 to date to 1,739. In Karachi, a total of 15,224 cases of XDR typhoid fever were reported from January 01, 2017 to Aug 14, 2021, with more than 7000 cases reported in 2019 alone. The XDR Typhoid cases were reported mostly among the children and maximum number of XDR cases 6381 (42%) were reported in the age group 0-4 years. Another 5,905 cases were reported in Sindh province (excluding Karachi) since 2016, with 70 percent reported from the District Hyderabad. Typhoid fever, caused by the bacterium Salmonella typhi, is a life-threatening bacterial infection. Typhoid fever is still common in the developing world, where it affects about 21 million people annually. Salmonella typhi lives only in  humans . Persons with typhoid fever carry the  bacteria in  their bloodstream and  intestinal tract . In addition

Ivermectin prescriptions up dramatically, Poison control receives five-fold increase in calls Outbreak news

  Ivermectin is a U.S. Food and Drug Administration  (FDA)-approved   prescription medication used to treat certain infections caused by internal and external parasites. During the COVID-19 pandemic, ivermectin dispensing by retail pharmacies has increased, as has use of veterinary formulations available over the counter but not intended for human use. Ivermectin is not authorized or approved by FDA for prevention or treatment of COVID-19.  The National Institutes of Health’s (NIH)   COVID-19 Treatment Guidelines Panel has also determined that there are currently insufficient data to recommend ivermectin for treatment of COVID-19. A recent study examining trends in ivermectin dispensing from outpatient retail pharmacies in the United States during the COVID-19 pandemic showed an increase from an average of 3,600 prescriptions per week at the prepandemic baseline (March 16, 2019–March 13, 2020) to a peak of 39,000 prescriptions in the week ending on January 8, 2021.1 Since early July 20

BioNTech selects Rwanda, Senegal for potential malaria and tuberculosis mRNA vaccine manufacturing Fiercepharma

BioNTech hopes it can follow up its global COVID-19 success with the world’s first mRNA vaccines against malaria and tuberculosis. While still under development, the German biotech is already eyeing two African countries to scale up production for the potential shots.  BioNTech, in its bid to become a “global immunotherapy powerhouse,” announced that it’s looking to build mRNA manufacturing sites in Rwanda and Senegal to support future production of the two vaccine hopefuls, the company  said  Friday.  The sites would provide “end-to-end vaccine supply solutions on the African continent.” Africa’s vaccine supply chain has come into sharp focus during the COVID-19 pandemic, since low- to middle-income countries have had to wait for their first shipments of vaccines behind richer countries, which snapped up initial supplies.  Malaria is an acute problem for Africa. The continent experienced a disproportionately high rate of deaths due to the mosquito-borne illness in 2019, accounting for

Microbiome startups promise to improve your gut health, but is the science solid? Fier

  After Russell Jordan sent a stool sample through the mail to microbiome company Viome, his idea of what he should eat shifted. The gym owner in Sacramento, California, had always consumed large quantities of leafy greens. But the results from the test—which sequenced and analyzed the microbes in a pea-sized stool sample—recommended he steer clear of spinach, kale and broccoli. “Things I’ve been eating for the better part of 30 years,” said Jordan, 31. “And it worked.” Soon, his mild indigestion subsided. He recommended the product to his girlfriend. She took the test in late February, when the company—which sells its Gut Intelligence test for $129 along with a more extensive Health Intelligence test, which requires a blood sample, for $199—began experiencing hiccups. Viome had promised results within four weeks once the sample arrived at a testing facility, but Jordan said his girlfriend has been waiting more than five months and has submitted fresh blood and stool samples—twice. Oth

Massachusetts biopharmas claim state's 3rd-largest VC funding year on record in a single quarter at $4.3B Fiercebiotech

  If you're going to call one state home, make it Massachusetts, says a host of biopharma startups that raised an eye-popping $4.3 billion in venture capital cash in just one quarter. The first quarter haul for the New England state is close to the $5.8 billion record set for all of 2020 and makes the first three months of this year the third-highest funding total on record, surpassing the bronze spot notched in 2017. That's according to  new data  released by the Massachusetts Biotechnology Council, or MassBio, and commercial biopharma analysis data from Evaluate and federal sources. To put that number in perspective, the overall biopharma industry was estimated to have raised $20.3 billion across the first two quarters of this year, according to a Silicon Valley Bank report.  Oncology, central nervous system and anti-infectives led the way for top financings in the first half. The startup haul was elevated by ElevateBio's $525 million series C, which claimed gold for top

Anti-aging foundation SENS fires de Grey after allegations he interfered with investigation into his conduct Fiercebiotech

Anti-aging research group the SENS Research Foundation has fired chief science officer Aubrey de Grey, who was accused of sexual harassment by two women earlier this month. The separation is effective immediately, according to an Aug. 21  statement from SENS  posted on its website and on Twitter. The organization made the move after de Grey indirectly attempted to pressure one of the participants in the ongoing investigation into his conduct. “This separation is not a decision we took lightly. It was, however, necessary,” read the statement, which also noted de Grey’s “indelible” impact on shaping the foundation. An investigation into de Grey’s conduct, which is being overseen by a third-party investigator, will continue. De Grey responded in a lengthy and rambling statement on his Facebook page, admitting to contacting Celine Halioua who has accused the anti-aging researcher of being a sexual predator. Halioua is CEO of the biotech Loyal, which is working to extend the lives of dogs a

Sabatini, biotech founder and mTOR pioneer, ousted after sexual harassment investigation Fierce Biotech

  David Sabatini, M.D., Ph.D., scientific founder of several biotechs, has been ousted from his lab after a sexual harassment investigation. The high-profile cell signaling and cancer metabolism scientist is “no longer associated” with either the Whitehead Institute or the Howard Hughes Medical Institute.  Sabatini is best known as one of the discoverers of mTOR. The discovery, which led Sabatini to  refer  to himself as mTORman, spurred research that established mTOR as a key regulator of growth in animals. Deregulation of the protein kinase is linked to diseases including cancer and epilepsy. Drugs including Novartis’ Afinitor and Pfizer’s Torisel inhibit mTOR. More recently, Sabatini has helped set up Navitor Pharmaceuticals, Raze Therapeutics and KSQ Therapeutics as a scientific founder. The biotechs built on Sabatini’s research into areas including cell nutrient signaling and cancer metabolism. Ruth Lehmann, Ph.D., director of the Whitehead Institute, emailed staff Friday to discl

After Aduhelm fallout, FDA veteran Woodcock out of running for commish job: report FierceBiotech

 Janet Woodcock, M.D., has spent more than three decades at the FDA, but her time running the agency as its interim leader is looking less likely to materialize into a full-time gig. After the departure of Stephen Hahn, M.D., the former President Donald Trump pick for FDA commissioner, President Joe Biden installed Woodcock into the chair for the short term as he looked for a replacement. Many thought Woodcock would be a shoo-in, but as we approach Nov. 15 when her temporary term is up, a report out by Bloomberg says the White House has now dismissed her as a candidate. This also seems borne out by the fact that during the worst pandemic in more than a century, with the FDA front and center (though sometimes behind the president) in authorizing or approving new drugs and vaccines, we still have no full-time commissioner. It would seem easy to simply move Woodcock into that role and have her confirmed, and get on with the job of dealing with the pandemic. But that hasn’t happened. Woodc

Stryker president lays out 2-year retirement plan after three decades with the company Fiercebiotech

  After spending his entire 30-plus-year career at Stryker, Timothy Scannell will soon part ways with the medical device maker to (ahem) strike a new path—one leading straight to retirement. Scannell has held a variety of roles at Stryker throughout his time there, capped off with a three-year stint as president and chief operating officer. He’ll step down from those roles at the beginning of October. At that time, his COO duties—spanning business development and both corporate and regional strategy—will be split between Andy Pierce and Spencer Stiles, currently the presidents of Stryker’s medsurg and neurotechnology, and orthopedics and spine sectors, respectively. Meanwhile, CEO and Chairman Kevin Lobo will take on the title of president, which he previously held for several years before Scannell stepped into the role. But while he’ll be leaving those day-to-day responsibilities behind, Scannell won’t fully sever ties with his longtime employer. Over the course of the following year

CSL's Seqirus delivers record number of flu vaccines despite pandemic, and now it's eyeing next-gen mRNA shots FierceBiotech

  Despite a global pandemic and social distancing measures threatening to hamper influenza vaccinations last season, CSL’s Seqirus managed to deliver a record number of flu shots—and it’s preparing to match that this season.  Seqirus, one of the largest flu vaccine makers in the world, shipped roughly 130 million flu vaccine doses globally last year, driving sales for the division up an impressive 30% at constant exchange rates to $1.7 billion, CSL reported in an annual filing on Wednesday.  The results for CSL’s Seqirus last year were “exceptionally strong,” driven primarily by its flu shot products amid the COVID-19 pandemic, CSL chief Paul Perreault said during a call with analysts.  In the U.S., Seqirus delivered 63 million flu vaccine doses last year. The company plans to deliver about 60 million this year, Dave Ross, Seqirus’ vice president of commercial operations in North America, told Fierce Pharma in an interview.  Some experts feared that lockdown orders and social distancin