Adderall is in short supply, according to the FDA Drug Shortages website.
Of the five companies that currently sell adderall, Mylan is
completely out of stock, Nesher can’t get the active ingredient and
Aurobindo has the drug under allocation. Only Teva and Sandoz show they
have Adderall available.
“The situation shows how sensitive the U.S. generic system has
become. There is limited spare capacity and even commodity products can
come out of stock,” analyst Ronny Gal, PhD, wrote to investors,
according to STAT.
https://www.beckershospitalreview.com/pharmacy/adderall-in-short-supply-fda-website-shows.html
Wednesday, October 23, 2019
South Korea warns of ‘serious risk’ from vaping, considers sales ban
South Korea on Wednesday advised people to stop using liquid
e-cigarettes due to growing health concerns and vowed to speed up an
investigation into whether to ban sales, a move likely to hit major
producers such as Juul and local tobacco company KT&G.
While long-term health impacts from vaping remain largely unknown,
e-cigarettes were viewed as a healthier alternative that could help
users quit smoking when they were first launched a few years ago.
But countries around the world have been pulling electronic cigarette products from markets and restricting advertising as vaping faces increased scrutiny.
“The current situation is considered as a serious risk to public
health,” South Korea’s health minister Park Neung-hoo told a briefing,
citing cases of lung injuries associated with e-cigarette use in the
United States.
U.S. health officials have so far reported 33 deaths and 1,479 confirmed and probable cases from a mysterious respiratory illness tied to vaping.
A pneumonia case of a 30-year old South Korean e-cigarette user was reported this month, the health ministry said.
“Children, juveniles, pregnant women, and people with pulmonary
diseases, never use liquid e-cigarettes. Non-smokers, too, never use
liquid e-cigarettes from now,” Park said.
Park said the government would speed up its own studies to determine if there was a scientific basis to ban sales of liquid e-cigarettes, which vaporize liquid containing nicotine.
A rival technology, which heats but does not burn tobacco, has been authorized by the U.S. Food and Drug Administration (FDA) and has avoided much of the recent regulatory crackdown globally.
The South Korean office of U.S. e-cigarette maker Juul Labs said in a statement their products had no harmful substances. Juul, 35% owned by Altria Group Inc, began selling its devices in South Korea in May.
KT&G Corp, a South Korean tobacco maker which sells Lil Vapour e-cigarettes, said it would cooperate with the government’s policies after results of the ongoing probe came out.
Since smoking was banned indoors at places like restaurants and cafés in 2015, South Korea become less tolerant of smokers. But e-cigarettes have been gaining popularity in the country’s $16 billion tobacco market since 2017.
E-cigarettes accounted for 13% of South Korea’s tobacco market by sales as of June, according to government data.
South Korea is the world’s No.2 market of heated vape products after Japan, worth $1.7 billion, according to Euromonitor, but liquid e-cigarettes are less popular.
The United States has already announced plans to remove flavoured e-cigarettes from stores, citing alarming growth in teenage use of the products
India also discontinued the sale of e-cigarettes in September, warning of an “epidemic” among young people.
https://www.reuters.com/article/us-health-vaping-southkorea/south-korea-warns-of-serious-risk-from-vaping-considers-sales-ban-idUSKBN1X205E
But countries around the world have been pulling electronic cigarette products from markets and restricting advertising as vaping faces increased scrutiny.
U.S. health officials have so far reported 33 deaths and 1,479 confirmed and probable cases from a mysterious respiratory illness tied to vaping.
A pneumonia case of a 30-year old South Korean e-cigarette user was reported this month, the health ministry said.
A man vapes in Seoul, South Korea, October 23, 2019. REUTERS/Heo Ran
Park said the government would speed up its own studies to determine if there was a scientific basis to ban sales of liquid e-cigarettes, which vaporize liquid containing nicotine.
A rival technology, which heats but does not burn tobacco, has been authorized by the U.S. Food and Drug Administration (FDA) and has avoided much of the recent regulatory crackdown globally.
REGULATORY CRACKDOWN
South Korea’s health ministry vowed to tighten regulations on vaping products such as strengthening customs procedures for imported liquid of e-cigarettes.The South Korean office of U.S. e-cigarette maker Juul Labs said in a statement their products had no harmful substances. Juul, 35% owned by Altria Group Inc, began selling its devices in South Korea in May.
KT&G Corp, a South Korean tobacco maker which sells Lil Vapour e-cigarettes, said it would cooperate with the government’s policies after results of the ongoing probe came out.
Since smoking was banned indoors at places like restaurants and cafés in 2015, South Korea become less tolerant of smokers. But e-cigarettes have been gaining popularity in the country’s $16 billion tobacco market since 2017.
A man uses a vape device in Seoul, South Korea, October 23, 2019. REUTERS/Heo Ran
South Korea is the world’s No.2 market of heated vape products after Japan, worth $1.7 billion, according to Euromonitor, but liquid e-cigarettes are less popular.
The United States has already announced plans to remove flavoured e-cigarettes from stores, citing alarming growth in teenage use of the products
India also discontinued the sale of e-cigarettes in September, warning of an “epidemic” among young people.
https://www.reuters.com/article/us-health-vaping-southkorea/south-korea-warns-of-serious-risk-from-vaping-considers-sales-ban-idUSKBN1X205E
Biogen, Eisai revive plans for Alzheimer’s drug, surprising market
Biogen Inc revived plans on Tuesday to seek U.S. approval for Alzheimer’s treatment aducanumab, surprising investors and saying data from more patients in two discontinued studies showed the drug reduced the decline of patients.
The drugmaker’s shares soared 27% in New York trading, recouping
almost all of the $18 billion it lost when it said in March it was
abandoning the two studies. Shares in Eisai Co, Biogen’s Japanese partner in the drug, were quoted up 18% to the daily limit high of 6,534 yen in Tokyo trading.
The field of experimental Alzheimer’s treatments is littered with high-profile failures, with many major drugmakers abandoning the race to develop a medicine for a disease that makes up 60%-70% of an estimated 50 million dementia cases globally.
Any medicine that effectively treats the disease is likely to become one of the world’s top-selling drugs and could be transformative for Biogen, which is facing multiple challenges over its product pipeline.
Filing with U.S. regulators could “potentially bring back to life a drug that had been completely left for dead,” RBC Capital Markets analyst Brian Abrahams wrote in a note.
“The viability of such a filing is unknown, given the mixed results – in our view, Biogen is somewhat desperate for growth drivers … so a change in narrative is badly needed.”
Biogen and Eisai decided to end the two late-stage trials of aducanumab in March when a so-called “futility analysis” revealed the trials had little hope of succeeding.
The failure spurred demands on Wall Street for the company to spend more on acquisitions, as its mainstay multiple-sclerosis franchise faced patent challenges and its newer muscle-wasting disorder treatment, Spinraza, faced competition from Switzerland’s Novartis.
UPHILL BATTLE
Biogen said on Tuesday more data had become available after the two studies were discontinued, resulting in new analysis that showed one of the trials met the main goal, while the other did not.
Results from patients in the failed second trial who had received high doses also supported the findings of the first, it added. Patients who received aducanumab experienced significant benefits on measures of cognition and function such as memory, orientation and language.
Biogen said it had met with the Food and Drug Administration twice, once in June and again on Monday to discuss the data.
“They (FDA) thought it was reasonable for us to submit an application for approval,” said Chief Medical Officer Alfred Sandrock, who earlier this month became the company’s R&D head.
Credit Suisse analyst Fumiyoshi Sakai said the new datasets would be presented at clinical trials meetings in early December. FDA approval was not guaranteed, and investors and analysts would remain cautious “until we see a real product,” he said.
The company said it planned to submit a marketing application for aducanumab in early 2020 based on the discussions.
Baird analyst Brian Skorney said he believed FDA approval for aducanumab was highly unlikely and predicted Biogen would have an uphill task to convince regulators that the results were more than random chance.
Aducanumab works on the hypothesis that removing deposits of amyloid, a type of plaque, from the brain of patients in the early stages of the disease could stave off its ravages, which include loss of memory and the inability to care for oneself.
Biogen executives on a conference call said the results from the new analysis were positive for another Alzheimer’s drug, BAN2401, which works on a similar principal and is also being jointly developed along with Eisai.
The company also reported a better-than-expected third-quarter profit, helped by higher demand for rare muscle disease drug, Spinraza. (http://bit.ly/2N0C8ed)
Shares in the company, which had lost 25.7% of its value this year as of Monday’s close, rose 27% to $284.
The field of experimental Alzheimer’s treatments is littered with high-profile failures, with many major drugmakers abandoning the race to develop a medicine for a disease that makes up 60%-70% of an estimated 50 million dementia cases globally.
Any medicine that effectively treats the disease is likely to become one of the world’s top-selling drugs and could be transformative for Biogen, which is facing multiple challenges over its product pipeline.
Filing with U.S. regulators could “potentially bring back to life a drug that had been completely left for dead,” RBC Capital Markets analyst Brian Abrahams wrote in a note.
“The viability of such a filing is unknown, given the mixed results – in our view, Biogen is somewhat desperate for growth drivers … so a change in narrative is badly needed.”
Biogen and Eisai decided to end the two late-stage trials of aducanumab in March when a so-called “futility analysis” revealed the trials had little hope of succeeding.
The failure spurred demands on Wall Street for the company to spend more on acquisitions, as its mainstay multiple-sclerosis franchise faced patent challenges and its newer muscle-wasting disorder treatment, Spinraza, faced competition from Switzerland’s Novartis.
UPHILL BATTLE
Biogen said on Tuesday more data had become available after the two studies were discontinued, resulting in new analysis that showed one of the trials met the main goal, while the other did not.
Results from patients in the failed second trial who had received high doses also supported the findings of the first, it added. Patients who received aducanumab experienced significant benefits on measures of cognition and function such as memory, orientation and language.
Biogen said it had met with the Food and Drug Administration twice, once in June and again on Monday to discuss the data.
“They (FDA) thought it was reasonable for us to submit an application for approval,” said Chief Medical Officer Alfred Sandrock, who earlier this month became the company’s R&D head.
Credit Suisse analyst Fumiyoshi Sakai said the new datasets would be presented at clinical trials meetings in early December. FDA approval was not guaranteed, and investors and analysts would remain cautious “until we see a real product,” he said.
The company said it planned to submit a marketing application for aducanumab in early 2020 based on the discussions.
Baird analyst Brian Skorney said he believed FDA approval for aducanumab was highly unlikely and predicted Biogen would have an uphill task to convince regulators that the results were more than random chance.
Aducanumab works on the hypothesis that removing deposits of amyloid, a type of plaque, from the brain of patients in the early stages of the disease could stave off its ravages, which include loss of memory and the inability to care for oneself.
Biogen executives on a conference call said the results from the new analysis were positive for another Alzheimer’s drug, BAN2401, which works on a similar principal and is also being jointly developed along with Eisai.
The company also reported a better-than-expected third-quarter profit, helped by higher demand for rare muscle disease drug, Spinraza. (http://bit.ly/2N0C8ed)
Shares in the company, which had lost 25.7% of its value this year as of Monday’s close, rose 27% to $284.
https://www.marketscreener.com/EISAI-CO-LTD-6492461/news/Biogen-Eisai-revive-plans-for-Alzheimer-s-drug-surprising-market-29437012/
Healthcare Services Group Q3 earnings down 30%
Healthcare Services Group (NASDAQ:HCSG) Q3 results:
Revenues: $455.6M (-9.9%). Shortfall driven by recent exit from facilities affiliated with a New York-based ownership group.
Net income: $18.3M (-29.9%); EPS: $0.25 (-28.6%).
Cash flow ops: $60M.
Shares down 1% after hours.
https://seekingalpha.com/news/3508111-healthcare-services-group-q3-earnings-30-percent
Tuesday, October 22, 2019
Cancer biotech RAPT Therapeutics revives IPO with an updated filing
RAPT Therapeutics, a Phase 1 biotech developing
therapies for cancer and inflammatory diseases, filed an amendment on
Tuesday with the SEC. It had previously filed in July 2019 to raise $75
million by offering 5 million shares at a range of $14 to $16, to
command a fully diluted market value of $351 million,
before postponing on August 1, 2019.
In the latest filing, BofA Merrill Lynch is no longer the lead
bookrunner. The company updated their financials as of June 30, 2019. It
also removed the VP of Human Resources and added independent director
Wendye Robbins, CEO of Blade Therapeutics. Lead inflammation drug
candidate RPT193 entered the clinic in August 2019.The South San Francisco, CA-based company was founded in 2015 and plans to list on the Nasdaq under the symbol RAPT. RAPT Therapeutics filed confidentially on May 24, 2019. BMO Capital Markets, Wells Fargo Securities, and UBS Investment Bank are the joint bookrunners on the deal. No pricing terms were disclosed.
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