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Monday, February 3, 2020

Clovis Oncology’s Rubraca now available in France; shares up

Clovis Oncology (NASDAQ:CLVS) announces that Rubraca (rucaparib), an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 is now available and reimbursed in France.
Rubraca is an option for monotherapy maintenance treatment for adults with relapsed, platinum-sensitive high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer that has responded to platinum-based chemotherapy.
With Rubraca now available in France, it is now a treatment option for eligible patients in Germany, England and Italy.
Shares are up 4% premarket.
https://seekingalpha.com/news/3537241-clovis-oncologys-rubraca-now-available-in-france-shares-up-4-premarket

Insmed up 48% premarket on positive INS1007 data

Insmed (NASDAQ:INSM) jumps 48% premarket on increased volume in reaction to positive results from a Phase 2 clinical trial, WILLOW, evaluating INS1007 in adults with non-cystic fibrosis bronchiectasis (NCFBE).
Both doses tested (10 mg and 25 mg) met the primary endpoint of time to first pulmonary exacerbation over a 24-week treatment period compared to placebo. A key secondary endpoint, frequency of pulmonary exacerbations, was also met.
On the safety front, INS1007, an inhibitor of an enzyme called dipeptidyl peptidase 1 (DPP1), was generally well-tolerated. The rates of adverse events in the 10 mg, 25 mg and placebo arms leading to discontinuation were 7.4%, 6.7% and 10.6%, respectively. The most common treatment-related adverse events were cough, headache, sputum increase, dyspnea, fatigue and upper respiratory tract infection.
Adverse events of special interest were periodontal disease (7.4% and 10.1% and 2.4%, respectively), hyperkeratosis (thickening of the skin’s outer layer) (3.7%, 1.1% and 0%, respectively) and infection rates (16.0%, 16.9% and 18.8%, respectively).
Detailed results will be submitted for presentation at a future medical conference and will be discussed during the company’s upcoming Q4 earnings call.
https://seekingalpha.com/news/3537247-insmed-up-48-premarket-on-positive-ins1007-data

FDA accepts Merck application for expanded use of Recarbrio

The FDA has accepted for review Merck’s (NYSE:MRK) supplemental marketing application seeking approval to use combo antibiotic Recarbrio (imipenem, cilastatin and relebactam) to treat adult patients with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by certain susceptible Gram-negative microorganisms.
The agency’s action date is June 4.
The FDA approved Recarbrio in June 2019 for complicated urinary tract and complicated intra-abdominal bacterial infections.
https://seekingalpha.com/news/3537216-fda-accepts-merck-application-for-expanded-use-of-recarbrio

Anavex up 12% premarket on Fast Track of lead candidate for Rett syndrome

Anavex Life Sciences (NASDAQ:AVXL) is up 12% premarket on average volume in response to its announcement that the FDA has designated AVAVEX 2-73 (blarcamesine) for Fast Track review for the treatment of Rett syndrome, a rare inherited neurological disorder occurring primarily in girls.
Fast Track status provides for more frequent interaction with the FDA review team and a rolling review of the marketing application.
Phase 2 studies (AVATAR and 001) are ongoing.
https://seekingalpha.com/news/3537211-anavex-up-12-premarket-on-fast-track-of-lead-candidate-for-rett-syndrome

Gilead +12% on coronavirus treatment testing

Shares of Gilead Sciences (NASDAQ:GILD) are up 12% in premarket action after formalizing an agreement with Chinese authorities to study the effectiveness of an experimental Ebola and SARS treatment on patients infected with the coronavirus.
“Gilead is working with health authorities in China to establish a randomized, controlled trial to determine whether remdesivir can safely and effectively be used to treat 2019-nCoV,” the company said in a statement. “While there are no antiviral data for remdesivir that show activity against 2019-nCoV at this time, available data in other coronaviruses give us hope.”
Trials for the drug will be conducted in Wuhan, the central Chinese city that is ground zero for the current outbreak.
https://seekingalpha.com/news/3537139-gileadplus-12-on-coronavirus-treatment-testing

Sunday, February 2, 2020

Exscientia claims world first as AI-created drug enters clinic

Drug discovery firm Exscientia has claimed a world first after announcing that the first precision engineered drug generated by artificial intelligence (AI) is entering clinical trials.
UK-based Exscientia has been working with Japanese pharma Sumitomo Dainippon Pharma (DSP) on the drug for obsessive-compulsive disorder (OCD), and the trial aims to measure its efficacy.
Exscientia said this is a milestone for drug discovery, as the entire project took 12 months instead of the usual five years.
The candidate compound was found within 350 synthesised compounds instead of the typical 2,500 compounds.
According to Exscientia, this could herald a new era of AI-driven drug discovery and expects nearly all new drugs entering the clinic to be discovered with the help of the technology.
DSP-1181 was created with DSP’s experience and monoamine G protein-coupled receptor drug discovery and Exscientia’s technology, known as Centaur Chemist.
The drug is a long-acting and potent serotonin 5-HT1A receptor agonist and will be added to DSP’s psychiatry and neurology research pipeline.
Paul Workman, chief executive of The Institute of Cancer Research, said: “I’m excited to see what I believe is the first example of a new drug now entering human clinical trials that was created by scientists using AI in a major way to guide and speed up discovery.
“This is very different from the use of AI to repurpose drugs. Success stories like this will provide us with the hard evidence that AI really will deliver on its transformative potential.”
Andrew Hopkins, CEO of Exscientia, said: “We believe that this entry of DSP-1181, created using AI, into clinical studies is a key milestone in drug discovery.”
AI in drug discovery is evolving fast – in September last year another R&D house, Deep Genomics, said it had used artificial intelligence to identify a therapeutic drug candidate for the first time.
While many companies are using AI as a guide in the process, the Canadian firm’s CEO Brendan Frey said at the Elevate Festival in Toronto that this was the first time an AI platform has identified and confirmed multiple genetic variants that cause Wilson’s disease, and found a drug candidate that matches the target.
Weeks earlier, Hong Kong’s Insilico Medicine said it found a way to use AI and deep learning to design, synthesise and validate a novel drug candidate in 46 days – 15 times faster than the best pharma companies.
Exscientia claims world first as AI-created drug enters clinic

Coronavirus (2019-nCoV): Frequently Asked Questions for Clinicians

The Wuhan coronavirus (2019-nCoV) outbreak has unfolded so rapidly that many clinicians are scrambling to stay on top of it. Here are the answers to some frequently asked questions about how to prepare your clinic to respond to this outbreak.
Keep in mind that the outbreak is moving rapidly. Though scientific and epidemiologic knowledge has increased at unprecedented speed, there is much we don’t know, and some of what we think we know will change. Follow the links for the most up-to-date information.

What should our clinic do first?

Plan ahead with the following:
  • Develop a plan for office staff to take travel histories from anyone with a respiratory illness, and provide training for those who need it. Travel history at present should include asking about travel to China in the past 14 days, specifically Wuhan city or Hubei province.
  • Review up-to-date infection control practices with all office staff and provide training for those who need it.
  • Take an inventory of supplies of personal protective equipment (PPE), such as gowns, gloves, masks, eye protection, and N95 respirators or powered air-purifying respirators (PAPRs), and order items that are missing or low in stock.
  • Fit-test users of N95 masks for maximal effectiveness.
  • Plan where a potential patient would be isolated while obtaining expert advice.
  • Know whom to contact at the state or local health department if you have a patient with the appropriate travel history.
The Centers for Disease Control and Prevention (CDC) has prepared a toolkit to help frontline healthcare professionals prepare for this virus. Providers need to stay up-to-date on the latest recommendations, as the situation is changing rapidly.

When should I suspect 2019-nCoV illness, and what should I do?

Take the following steps to assess the concern and respond:
  • If a patient with respiratory illness has traveled to China in the past 14 days, immediately put a mask on the patient and move the individual to a private room. Use a negative-pressure room if available.
  • Put on appropriate PPE (including gloves, gown, eye protection, and mask) for contact, droplet, and airborne precautions. CDC recommends an N95 respirator mask if available, although we don’t know yet if there is true airborne spread.
  • Obtain an accurate travel history, including dates and cities. (Tip: Get the correct spelling, as the English spelling of cities in China can cause confusion.)
  • If the patient meets the current CDC definition of “person under investigation” (PUI), or if you need guidance on how to proceed, notify infection control (if you are in a facility that has it) and call your state or local health department immediately.
  • Contact public health authorities who can help decide whether the patient should be admitted to airborne isolation or monitored at home with appropriate precautions.

What is the definition of a PUI?

The current definition of a PUI is a person who has fever and symptoms of a respiratory infection (cough, shortness of breath) AND who has EITHER been in Wuhan city or Hubei province in the past 14 days OR had close contact with a person either under investigation for 2019-nCoV infection or with confirmed infection. The definition of a PUI will change over time, so check this link.

How can I test for 2019-nCoV?

As of January 30, 2020, testing is by PCR and only available in the United States through CDC in Atlanta. Testing should soon be available in state health department laboratories. If public health authorities decide that your patient should be tested, they will instruct you on which samples to obtain.
The full sequence of 2019-nCoV has been shared, so some reference laboratories may develop and validate tests, ideally with assistance from CDC. If testing becomes available, make certain that it is a reputable lab that has carefully validated the test.

Should I test for other viruses?

Because the symptoms of 2019-nCoV infection overlap with those of influenza and other respiratory viruses, PCR testing for other viruses should be considered if it will change management (ie, change the decision to provide influenza antivirals). Use appropriate PPE while collecting specimens, including eye protection. If 2019-nCoV is a consideration, you may want to send the specimen to a hospital lab for testing, where the sample will be processed under a biosafety hood, rather than doing point-of-care testing in the office.

How dangerous is 2019-nCoV?

The current estimated mortality rate is 2%-3%. That is probably an overestimate, as those with severe disease and those who die are more likely to be tested and reported early in an epidemic.
Our current knowledge is based on preliminary reports from hospitalized patients and will probably change. From the speed of spread and a single family cluster, it seems likely that there are milder cases and perhaps asymptomatic infection.

What else do I need to know about coronaviruses?

Coronaviruses are a large and diverse group of viruses, many of which are animal viruses. Before the discovery of the 2019-nCoV, six coronaviruses were known to infect humans. Four of these (HKU1, NL63, OC43, and 229E) predominantly cause mild to moderate upper respiratory illness, and they are thought to be responsible for 10%-30% of colds. They occasionally cause viral pneumonia and can be detected by some commercial multiplex panels.
Two other coronaviruses have caused outbreaks of severe respiratory illness in people: SARS, which emerged in Southern China in 2002, and MERS in the Middle East, in 2012. Unlike SARS, sporadic cases of MERS continue to occur.
The current outbreak is caused by 2019-nCoV, a previously unknown beta coronavirus. It is most closely related (~96%) to a bat virus and shares about 80% sequence homology with SARS CoV.
Andrew T. Pavia, MD, is the George and Esther Gross Presidential Professor and chief of the division of pediatric infectious diseases at the University of Utah School of Medicine. His research interests include the epidemiology of influenza and other emerging infections, pneumonia, and vaccine-preventable diseases. He has published more than 250 articles, textbook chapters, reviews, and scientific abstracts.
https://www.medscape.com/viewarticle/924555#vp_1