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Fast Takes
Pharma CEOs in Davos put brave face on Trump presidency
How Takeda won a $5.2B bidding war -- against itself
Endpoints News
FDA Report: 22 Drugs That Passed Phase II But Crashed and Burned in Phase III
Forget about fake news, the FDA found fake quality control documents in China drug factory
Lilly to lay off about 500 in wake of Alzheimer's drug fail
Indy Star
Costco to pay $11.75 mln fine over lax U.S. pharmacy controls
Walgreens Faces U.S. Antitrust Concerns Over Rite Aid Fix
Indian Travel Boom Is Sending Tourists Home With Superbugs

1/23 Mallinckrodt Pays $100 Million Fine To Settle Allegations Regarding
Pricing Of Its #1 Moneymaker Acthar
- Legacy company killed off Acthar competition, boosted price from $40 to $34,000
Mallinckrodt to pay $100 million to settle US probe on drug pricing … broke U.S. antitrust law by sharply increasing the price of a multiple sclerosis drug while ensuring that no rival medicine appeared on the market  … [CNBC]
Mallinckrodt's Worries Aren't Over … [Bloomberg]

FDA Spells Out Strict Requirements For Biosimilar Substitutability
- Draft guidance ensures it won't be easy to claim substitutability
FDA spells out expectations on biosimilar interchangeability … In order for a biosimilar to be judged "interchangeable" with its reference biologic, drugmakers will need to prove the biosimilar produces the same clinical result as the other drug in any given patient and across all of that drug's approved indications … [Biopharma Dive]
Bad news for biosim makers: FDA sets 'high bar' in interchangeability guidance … interchangeability isn't required for an approval … Winning the designation won't be easy, but a big payoff could await for those who do … [Fierce Pharma]

Sanofi's Unfruitful M&A Track Record Frustrate Some Investors
- Impatient fund managers cite probable loss of  Actelion to JNJ,  losing Medivation to Pfizer
Sanofi's M&A misses frustrate some investors in drugmaker … Investors growing impatient after it fails to land acquisitions …  shareholders are fed up with Sanofi and tired of seeing the stock in this 'vegetative' state … Cost cutting is not enough, we want to see growth in sales … [Reuters]

Insys: Drug Rep Testimony Describes Alleged Non-kosher 
Tactics To Boost Fentanyl Sales
Pharma reps testify in 'pill mill' case … salesman was Joseph A. Rowan, 43, who was one of the six ensnared by an indictment last month in Massachusetts … program started as "educational" and "beneficial" but became a way to reward doctors who frequently Subsys prescriptions … doled out according to the amount of prescriptions that were written." … []

Keytruda, Opdivo Patent Suit: Merck Resolves Dispute With Bristol, Ono
- Ponies up big bucks, royalties, won't have to withdraw product
Merck, Bristol-Myers and Ono Pharma agree to settle Keytruda patent suit … Merck will make an initial payment of $625 million to Bristol and Japan's Ono. The company will also pay a 6.5 percent royalty rate on Keytruda sales from January 2017 to December 2023, and a 2.5 percent rate for the subsequent three years … [Nikkei Asian Review]

1/20 Price's Office Pushed AHRQ to Remove BiDil Study from Site
When a Study Cast Doubt on a Heart Pill, the Drug Company Turned to Tom Price .... After hearing from a company whose CEO was a campaign contributor, a congressional aide to Donald Trump's HHS nominee repeatedly pushed a federal health agency to remove a critical drug study from its website. .... ProPublica

1/20 73% of Seniors in Part D Plans Enrolled in Narrow Networks
New 2017 Part D Enrollment Data: Walgreens and Walmart Trounce CVS in Preferred Networks .... The three biggest companies—Humana, UnitedHealthcare, and CVS Health's SilverScript—now account for 69% of enrollment in stand-alone Part D plans .... Drug Channels

1/20 Trulance Gets FDA OK
FDA approves Trulance for Chronic Idiopathic Constipation .... Participants receiving Trulance were more likely to experience improvement in the frequency of complete spontaneous bowel movements than those receiving placebo, and also had improvements in stool frequency and consistency and straining .... FDA News Release

1/20 FDA Sets "Consistent with Label" Test for Promotions
In draft guidance, the FDA defines appropriate off-label comms as being 'consistent' with the label .... number of examples of ways pharma companies can share information ... data about long-term safety and efficacy of products that treat a chronic condition; updates from head-to-head trials .... MM&M

1/20 FDA Gets Everything Out the Door Before the New Administration: Report Released on Phase 2 vs Phase 3 Differing Results
22 Case Studies Where Phase 2 and 3 Results Diverge: New FDA Report .... Of the 22 case examples, Phase 3 studies did not confirm Phase 2 findings of effectiveness in 14 cases, safety in one case, and both safety and effectiveness in seven cases .... Regulatory Focus

1/20 AEs Reported with Lemtrada
Researchers Report Severe Adverse Effects of MS Drug Alemtuzumab .... Using magnetic resonance imaging, the researchers discovered a new mode of inflammation: they found areas in the brain with numerous ring-enhancing lesions. The patients had not displayed this pattern in their previous medical histories .... PTCommunity

1/20 Frazier: Keytruda + Chemo Could Be Cheaper than Other Lung Cancer Options
Merck CEO sees Keytruda in pole position in cancer race .... The FDA is due to decide by May 10 whether to approve a combination of the immune system-boosting drug with chemotherapy as an initial therapy for advanced lung cancer .... Reuters

1/20 "Valeant Strategy" for Auvi-Q: Only a Few Chumps Pay List Price
In Rube Goldberg Price Scheme, EpiPen Competitor Auvi-Q To Be Free For Patients, $4,500 For Their Insurers .... Kaleo, Auvi-Q's manufacturer, will charge patients who have commercial insurance $0 for the product, whether or not the insurance company pays for it. It will also give the product away to families with an income of less than $100,000.... But the list price for Auvi-Q, and the starting point for insurance companies, will be much higher: $4,500 .... Forbes (autoplay ad)

1/20 Price Won't Let Himself Get Pinned Down on Price Negotiations
Tom Price, nominee to lead HHS, sidesteps questions on Medicare drug-pricing negotiations .... seemed to suggest that the policy would at least be considered, given Trump's outspoken support for it, but he expressed no enthusiasm .... Stat News

1/20 New Lineup at Top of GSK
GSK grabs Astra executive to replace pharma head .... GlaxoSmithKline's global head of pharmaceuticals, Abbas Hussain, is to leave Britain's biggest drugmaker after being passed over for the top job and will be replaced by Luke Miels from AstraZeneca. .... Reuters

1/20 Internet Drug News Fast Takes:
6 experts weigh in on how Obama changed health care
Advisory Board
What Trump's Libertarian Pals Don't Understand About The FDA -- Or Reality
Forbes/Matthew Herper
Novartis chief Jimenez touts two top PhIII drug prospects
Endpoints News
U.S. Health Agency Tells Grassley There Is No EpiPen Deal Yet
NY Times
Merck, Biogen, Lilly Top 2016 Drug Approvals Despite FDA Slump
Investors Business Daily

1/19 Drugmakers Lose 37% of List Price to Rebates, Discounts
Secret Rebates Erode Drugmaker Revenue, Industry Study Says .... Of the $349.1 billion that insurers and patients paid for brand-name drugs in 2015, $218.6 billion, or 63 percent.... Bloomberg

1/19 Novartis CEO: If America is Back for Business, We'll Be There
Trump tax cuts could mean more Novartis investment in U.S. .... "When we build a new manufacturing site we think about the tax rate, we think about the economy of the country, we think about jobs, so a booming U.S. economy would make the U.S. more attractive for investment," Joe Jimenez said .... Reuters

1/19 Mallinkrodt Pays for Strangling Rival in its Cradle
Mallinkrodt Reaches $100 Million Settlement with FTC .... Irish drugmaker Mallinkrodt has agreed to pay $100 million to settle Federal Trade Commission charges that it violated antitrust laws by buying the rights to an infantile-spasms drug that threatened its own rival product Acthar .... The Street (autoplay video)

1/19 Twittering Docs Don't Reveal Their COIs
What Your Doctor Isn't Telling You on Twitter .... Cancer doctors with Twitter accounts have something else in common: more than 70% of them receive funding from drug companies .... Time

1/19 FDA Sets High Hurdles for Biosimilars
FDA Issues Long-Awaited Biosimilar Interchangeability Guidance .... The guidance... recommends that sponsors looking to get a biosimilar approved as interchangeable with its reference product conduct one or more switching studies to show that patients can alternate between the two products safely and without diminished efficacy .... Regulatory Focus

1/19 "The Medicine Was So Good, I Bought the Company": Pundits Say if US Govt Bought Gilead, Cost to Treat Hep C Would Drop to a Third
Should the U.S. try M&A to save on hep C? Gilead would be a good buy, experts say .... Gilead's current market cap is about $100 billion. Offering a 30% premium to shareholders, and assuming the company's $26 billion in debt, would cost the U.S. $156 billion .... Fierce Pharma

1/19 FDA Appeared to Ramp Up Enforcement Letters in 2016
The FDA targeted DTC, video, unapproved drug promotion in 2016 .... FDA is taking a closer look at how drugmakers use channels like direct-to-consumer advertising and video, a shift .... MM&M

1/19 Durvalumab Delay Leaves AZN Behind the Pack in Immune-Oncology Race
AstraZeneca's Catch-Up Strategy is Falling Behind .... One of Astra's chosen paths to $40 billion was to become a major player in the rapidly growing IO market, which neared $10 billion in total sales last year. This approach was always a longshot, though... Astra's lead drug durvalumab is still awaiting its first approval .... Bloomberg Gadfly

1/19 2 for 5: In First Round of Testing, Most Attempts to Replicate Cancer Studies Fail
What Does It Mean When Cancer Findings Can't Be Reproduced? .... The first results from a major project to measure the reliability of cancer research have highlighted a big problem: Labs trying to repeat published experiments often can't. .... NPR Shots blog

1/19 Exclusivity Extensions Pay Off
US Six-Month Drug Market Exclusivity Extensions Could Yield Nearly $100 Million .... The median discounted financial gain for each drug would have been $94.6 million, with blockbuster drugs predictably enjoying the highest returns. The authors’ analysis also suggests that manufacturers had spent a median of $29.8 million on trials that gained supplemental approval for rare disease indications. .... Health Affairs blog

1/19 Internet Drug News Fast Takes:
New prescription: Doctor offices that look like Apple stores
Sanofi wins EU approval for new diabetes combination Suliqua
Can marijuana treat MS symptoms? It's hard for researchers to find out
The Conversation
A third of asthma patients are misdiagnosed, study finds
Medical News Today

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