1. Former CDC Chief Launches $225 million Global Health Initiative
Tom Frieden, former director of the
Centers for Disease Control and Prevention, is starting a new initiative to
tackle some of global health’s themiest issues: cardiovascular disease and
epidemics. The $225 million initiative, called Resolve, announced September
12th in New York, aims to reduce the global burden of heart disease and stroke,
the world’s leading causes of death. It also will focus on helping low- and
middle-income countries fight infectious disease epidemics by strengthening
laboratory networks so emerging threats are identified promptly, and training
disease detectives to track and investigate disease outbreaks, including those
that circulate in animals and jump to humans.
https://www.washingtonpost.com/news/to-your-health/wp/2017/09/12/former-cdc-chief-launches-new-global-health-initiative/?utm_
term=.5b631effed9c
2. Amgen Is Taking On a $3 Billion Cancer Drug. But Will It Cut Costs
for Patients?
The Food and Drug Administration
(FDA) continued its potentially record-breaking pace of new drug approvals,
green lighting the first-ever “biosimilar” copycat of a cancer drug. The new
treatment, U.S. biotech Amgen’s Mvasi, has a big target in its crosshairs:
Avastin, a versatile cancer therapy from drug maker Roche that rings in nearly
$7 billion in global annual sales, including $3 billion in America. Avastin is,
like many cancer drugs, extremely expensive. And that was one of the
motivations for introducing a clinically-proven competitor like Mvasi (also
known as bevacizumab-awwb) to the market. It’s unclear how Amgen and partner
Allergan will price Mvasi. http://fortune.com/2017/09/15/amgen-roche-avastin-biosimilar-price/
3. Pfizer Alleges J&J Thwarted Competition to Remicade, in Legal
Test of Biotech-Drug Copies
Pfizer Inc. filed suit against
Johnson & Johnson alleging J&J thwarted competition to its arthritis
therapy Remicade, in a case that could shatter arrangements pharmaceutical
companies make with insurers to protect their franchise products and threaten
efforts to bring down the costs of the most expensive drugs. The lawsuit is the
first antitrust action to surface amid the emergence of biosimilars, which are
copies of popular biotech drugs, after years of litigation over patents and
timing of launches. Pfizer’s Inflectra is the biosimilar of Remicade. Inflectra
was developed by Celltrion Inc. of South Korea. Pfizer has the rights to sell
the drug in the U.S. Scott Hemphill, a professor of antitrust law at New York
University School of Law, said Pfizer will need more than J&J’s contracts
with health insurers and hospitals to prevail.
https://www.wsj.com/articles/pfizer-files-antitrust-lawsuit-alleging-j-j-thwarted-use-of-biosimilar-rival-toremicade-1505913080
4. F.D.A. Approves Second Gene-Altering Treatment for Cancer
The Food and Drug Administration approved
the second in a radically new class of treatments that genetically reboot a
patient’s own immune cells to kill cancer. The new therapy, Yescarta, made by
Kite Pharma, was approved for adults with aggressive forms of a blood cancer,
non-Hodgkin’s lymphoma, who have undergone two regimens of chemotherapy that
failed. Before it was approved and named Yescarta, Kite’s treatment was known
by other names: axi-cel, axicabtagene ciloleucel, or KTE-C19. The company also
hopes that Yescarta will eventually be approved for earlier stages of lymphoma,
rather than being limited to patients with advanced disease who have been
debilitated by multiple types of chemotherapy that did not work, said Dr. David
D. Chang, Kite’s chief medical officer and executive vice president for
research and development. https://nyti.ms/2zjEtsf
5. How Would CVS and Aetna Fit Together?
CVS Health Corp. is reportedly in
talks to buy Aetna Inc. for more than $66 billion. Aetna became the biggest customer
of CVS’s PBM unit under a 12-year deal struck in 2010 between the two
companies. A combination with CVS would let Aetna push further into the
health-care-delivery space, as well as integrating the health coverage it
provides with all of CVS’s pharmacy-focused services and clinics. The real
growth opportunity for CVS is in the pharmacy-benefits business. Revenue and
profits for CVS’s pharmacy-services operations, comprising mainly the PBM
business, have been growing at a faster clip than the company’s retail
business.https://www.wsj.com/articles/behind-the-potential-cvs-aetna-deal-1509129970
6. U.S. Hospitals Wrestle with Shortages of Drug Supplies Made in
Puerto Rico
Hospital pharmacists across the
country are racing to find vital drugs after Hurricane Maria halted production
at the factory in Puerto Rico. In addition to creating a humanitarian crisis on
the island, the storm knocked out production at the Puerto Rican factories that
make vital drugs, medical devices and medical supplies that are used around the
world. In a recent interview, Dr. Gottlieb said he was worried that if
conditions don’t improve, more shortages — of both drugs and medical devices —
might follow by early next year. Pharmaceutical products made in Puerto Rico
account for nearly 10 percent of all drugs consumed by Americans, and about 80
firms make medical products there. https://nyti.ms/2zyhiup
7. Courts Reverse Johnson’s Baby Powder Judgments for Nearly $500
Million
In back-to-back victories for
Johnson & Johnson, the courts have reversed two judgments against the
consumer products giant totaling nearly $500 million. The money had been
awarded to women who said that they developed ovarian cancer after using the
company’s talcum powder for decades. In her ruling, Judge Maren E. Nelson
granted the company’s motion for a new trial. The judge cited the
“insufficiency of the evidence” and said that the damages awarded were
excessive. The potential dangers of talcum powder are a subject of debate
within the medical field, in part because the evidence varies. National health
organizations are cautious about drawing any firm conclusions. https://nyti.ms/2zwL3f5
8. Samsung Reports Operating Profit, Extends Collaboration with Merck
KGaA
Samsung reported a KRW 20.5 billion
operating profit ($18.2 million), on KRW 127.5 billion ($113.4 million) in
revenues for the quarter as its first plant runs at full pace and its second
facility continues to draw new contracts, the company said. Its net loss,
however, widened to 31.7 billion won ($28.2 million) from 9.6 billion won in
the same quarter a year ago, primarily because of “call option valuation losses
on its subsidiary company,” it reported. Under the reiterated deal first struck
in 2014, Merck will provide process development and some technical training for
its Mobius single-use technology which Samsung BioLogics uses. http://www.fiercepharma.com/manufacturing/samsung-reports-operating-profit-extends-collaboration-merck-kgaa
9. Novartis Picks Centerview To Explore Sale of Dermatology Unit:
Sources
Novartis is working with Centerview
to review options for its dermatology business, including a possible sale, as
it trims non-core assets. The mandate, which comes after Novartis’ $3.9 billion
purchase of French radiopharmaceutical firm Advanced Accelerator Applications
(AAA), is likely to pave the way for a sale of the group’s dermatology drugs,
which could fetch up to $ 1.5 billion. http://www.reuters.com/article/us-novartis-dermatology-m-a/novartis-picks-centerview-to-explore-sale-of-dermatologyunit-sources-idUSKBN1D22PA
10. As Amazon Entry into Pharma Looms, CEOs See Plenty of Room for
Change in Distribution
Online retailing giant Amazon has
yet to publicly disclose any plans to get into drug sales, but the mere
speculation has pharma CEOs thinking, and speaking, about how it could entirely
remake their world. Goldman Sachs analysts have put out a 30-page report
outlining several options for Amazon in pharmaceuticals, writing that a
partnership with an existing PBM is a “path of least resistance.” One Bernstein
analyst said he believes the company will have its pharmacy business set up by
2019 and ready to compete for business in 2020, while a Leerink analyst has
said “it’s a matter of when, not if” that Amazon will move into drugs. http://www.fiercepharma.com/pharma/drug-execs-see-amazon-s-potential-to-shake-up-distribution
11. New York City and State Battle Over Health-Care Funding
New York City and state officials
clashed over funding for the city’s public-health system amid looming federal
cuts. Officials with NYC Health Hospitals, which runs the city’s 11 public
hospitals, disclosed in a letter to the state that they have enough cash on
hand to operate for only about two weeks because they haven’t received $380
million from the state that they expected to be paid out earlier this year.
Gov. Andrew Cuomo’s administration said that the city is exaggerating its case,
as state officials prepare for a loss of about $2.6 billion in federal funding
over several years to hospitals statewide and look to reorganize state dollars.
The city’s public health system already is in dire financial straits. https://www.wsj.com/articles/new-york-city-and-state-battle-over-health-care-funding-1506985681unit-sourcesidUSKBN1D22PA
12. CVS Will Offer Next-Day Delivery of Prescription Drugs
CVS Health said that it would begin
offering next-day delivery of prescription drugs and same-day service in some
big cities next year, reflecting the company’s worries about potential
competition from Amazon and as its retail sales declined in the third quarter
of this year, a dip that the company said occurred because of the three major
hurricanes that forced many stores to close. A CVS spokeswoman, Erin Pensa,
said the company’s delivery partner has not been announced, but that they have
been able to use their scale to negotiate low-cost, affordable options for all
CVS Pharmacy customers. https://nyti.ms/2j4HWYS
13. Korean Cosmetics Maker Buys U.S. Firm for US $50 Million
Cosmax Co., a South Korean cosmetics
maker, has acquired a U.S. company for US$50 million to expand its foothold in
the North American market. The Korean company said it recently signed a
contract to buy all of NuWorld Beauty. Cosmax is the country’s leading original
design manufacturer (ODM), making products ranging from skincare to haircare
and facial masks. Cosmax said it will strengthen its production and marketing
capabilities, research and development following the acquisition, with an aim
to post 200 billion won ($178 million) in revenue in the U.S. market alone by
next year, and 3 trillion won worldwide by 2020. http://english.yonhapnews.co.kr/news/2017/11/13/0200000000AEN20171113008200320.html
14. Trump Chooses Alex Azar for Health and Human Services Secretary
President Trump nominated a
pharmaceutical executive to be the next secretary of the Health and Human
Services Department. The nominee, Alex M. Azar II, served as a deputy at the
department under former President George W. Bush. From 2011 to 2017, he was the
head of the pharmaceutical company Eli Lilly’s United States Division where he
worked for a decade. Mr. Trump said that Mr. Azar will play a key role for
better health care and lower drug prices, but the choice immediately raised new
doubts among some lawmakers and industry observers about the president’s stated
commitment to rein in drug companies. https://nyti.ms/2hwZgoN
15. Bill Gates Makes $100 Million Personal Investment to Fight
Alzheimer’s
Billionaire Microsoft co-founder
Bill Gates is to invest $50 million in the Dementia Discovery Fund. The
investment – a personal one and not part of Gates’ philanthropic Bill &
Melinda Gates Foundation – will be followed by another $50 million in start-up
ventures working in Alzheimer’s research, Gates said Despite decades of
scientific research, there is no treatment that can slow the progression of
Alzheimer’s. Current drugs can do no more than ease some of the symptoms. Gates
said, however, that with focused and well-funded innovation, he’s optimistic
that treatments can be found, even if they might be more than a decade away.
http://www.reuters.com/article/us-health-dementia-gates/bill-gates-makes-100-million-personal-investment-to-fightalzheimers-idUSKBN1DD0S3