CASI announced that it has received approval in China for Evomela. The drug is a formulation of melphalan hydrochloride used in the treatment of multiple myeloma, and CASI obtained the rights to the drug in Greater China from its original developer, Spectrum Pharmaceuticals, in 2014. This put CASI in a unique position to take advantage of the regulatory reforms in China. The drug was approved under the new priority review pathway at the National Medical Products Administration (NMPA, formerly the CFDA) and serves as a test case for this new regulatory regime.
Monday, December 10, 2018
LHC, LifePoint Health expand links with 2 acquisitions in NC, Virginia
LHC Group (NASDAQ: LHCG) and LifePoint Health® today announced the continued expansion of their partnership. The companies have finalized two transactions to purchase and share ownership of home health service providers in Hickory, N.C., and Danville, Va.
LHC Group and LifePoint formed a joint venture to share ownership of home health and hospice providers across LifePoint’s footprint in January 2017. In less than two years, the joint venture, which started with 20 home health and 10 hospice locations, has grown to include 33 home health, 14 hospice, and one home and community based services locations.
In Hickory, LHC Group and LifePoint are purchasing and sharing ownership of Guardian Health Services. LHC Group has majority ownership and will assume management responsibility of the agency, which will continue to provide service from its current location under a new name: Guardian Home Health. Guardian Home Health will be affiliated with Frye Regional Medical Center, which is part of Duke LifePoint Healthcare.
In Danville, LHC Group and LifePoint Health are purchasing and sharing ownership of Commonwealth Home Health Care. LHC Group has majority ownership and will assume management responsibility of the agency, which will continue to operate at its current location under the same name. Commonwealth Home Health Care will be affiliated with Sovah Health – Danville, a LifePoint Health facility.
“We look forward to continuing our work with our partners at LifePoint – expanding their post-acute presence and capabilities as they serve communities across America,” said Keith Myers, LHC Group chairman and CEO. “Together, we will grow these existing service lines, offer new services, and enhance our partners’ ability to provide high quality care to the patients and families they serve.”
By growing its relationships with LifePoint and other healthcare partners around the nation, LHC Group enhances its ability to provide post-acute care solutions. Hospitals and health systems increasingly seek a high-quality post-acute partner to help manage the transitioning of patients – making sure that they move through the post-acute care continuum as effectively and efficiently as possible.
“As the way people utilize healthcare services shifts, access to high-quality home health services has never been more essential,” said David Dill, CEO of LifePoint Health. “We are delighted to continue growing our joint venture with LHC Group to achieve a shared mission of making communities healthier, and look forward to working further with their team to expand the services we can provide across the nation.”
Malaysia takes action on world’s top med glovemaker after labor rights expose
Malaysia said on Monday it would take action against Top Glove Corp. Bhd, the world’s largest glovemaker, for breaching labour laws after a Thomson Reuters Foundation expose found some migrants working illegal overtime to pay off debts.
The Thomson Reuters Foundation revealed on Thursday that migrant workers at the Malaysian company often work long hours to earn overtime pay to clear debts to recruitment agents back home – and in some cases exceed the legal overtime limit.
Speaking at a press conference in Malaysia, Top Glove’s executive chairman and founder Lim Wee Chai said “a small number” of workers had done excessive overtime, and that the company would “continue to improve” its labour standards.
Malaysia’s Human Resources Minister M. Kulasegaran said “action will be taken” against Top Glove for the breach of labour laws on overtime hours.
“(The company) themselves admitted so we will take the necessary action,” he told reporters.
Malaysia’s labour ministry said Top Glove could face a fine of up to 10,000 Malaysian ringgit ($2,400) if found guilty of breaching laws on excessive overtime.
Samsung BioLogics shares to remain listed, resume trade on December 11
South Korea’s main stock exchange has decided Samsung BioLogics Co Ltd is qualified to continue trading on the exchange and that the company’s shares will resume trading on Tuesday, the bourse said on Monday.
Trading in shares of the biotech drug arm of the parent group of tech giant Samsung Electronics Co has been suspended since Nov. 14, immediately after the financial regulator said the company had intentionally breached accounting rules ahead of its listing in 2016.
“We concluded that there was no serious concern about the company’s continuity regarding its business outlook, order backlogs and order plans, as the company’s revenues and profitability were found to have improved,” the Korea Exchange said in a statement.
Samsung BioLogics said in a statement it would strengthen its internal control system and planned to prove the legitimacy of its accounting methods.
The company denied any wrongdoing following the financial watchdog’s ruling on accounting violations and filed an administrative lawsuit against it.
The regulator’s ruling was a blow to South Korea’s biggest conglomerate, which is banking on biopharmaceuticals for growth. It announced plans in August to invest $22 billion in the business and in other areas such as artificial intelligence and 5G mobile technology.
Weight Watcher (WTW) Nearing ‘Rock-Bottom’ Valuation – DA Davidson
DA Davidson analyst Linda Bolton Weiser said Weight Watchers (NASDAQ: WTW) is nearing ‘rock-bottom’ valuation and reiterated a Buy ratingg.
Intec Pharma expects to earn revenue from Parkinson’s pill in 2019
Intec Pharma, which is conducting a late stage trial for its long-lasting pill to treat Parkinson’s disease, expects to begin earning revenue from the program in 2019, Reuters reports, citing CEO Jeffrey Meckler.” I feel very comfortable that we have an approvable program here. I would like to see as big an effect size as possible, but there is commercial viability at any effect size. I hope next year we will be able to monetize value out of the Parkinson’s program, whether that is the sale of the company, sale of the program or a license partnership,” said Meckler, who said assuming a 10% market share, “We have a drug that is worth more than $300M a year.”
https://thefly.com/landingPageNews.php?id=2834651
Piper: RA data may be competitive to Alexion, but questions remain
After RA Pharmaceuticals (RARX) reported top-line results from its Phase 2 trial of zilucoplan in generalized myasthenia gravis, or gMG, Piper Jaffray analyst Christopher Raymond said the data generally looks more competitive than he would have expected. However, more details on patient background and safety are needed to make a direct comparison to Alexion’s (ALXN) Soliris, said Raymond, who thinks RA’s program is “worth monitoring.” He keeps an Overweight rating on Alexion shares, which are down 1% to $114.18 in early trading.
https://thefly.com/landingPageNews.php?id=2834671
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