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12/1 FDA Commissioner Wants Broader Accelerated-Approval Program
FDA Aims to Expand Early-Approval Program for Promising Drugs .... Typically, early trials are used to determine how best to craft larger studies and aren't used for approval. But Gottlieb wants early trials to be used for approval if they show an outsized survival benefit. Any drug cleared based on early-trial data would later have to be proven in larger trials to maintain the benefit .... Bloomberg
12/1 CVS-Aetna Deal Could Be Final this Weekend
CVS reportedly near deal to buy Aetna for around $66 billion .... An acquisition of an insurer like Aetna could give CVS more scale to bargain better prices for the prescription drugs it sells on its counters. It could fortify Aetna's insurance business by creating the ability to offer its insured cheaper copayments .... CNBC
12/1 Amazon May Be Heading for a Role in Drug Distribution
Amazon is in exploratory talks with generic-drug makers .... The conversations may be about Amazon taking a role in drug purchasing, competing against distributors like McKesson, AmerisourceBergen, and Cardinal Health .... CNBC (autoplay video)
12/1 CMS Head Throws Out Some Ideas on Expensive Drugs
U.S. health regulator Verma eyes new methods for drug pricing .... Verma said one model under consideration was paying different prices for a single drug based on its success treating a particular condition.... A second method would be to extend the payment of an extremely expensive medicine over a longer time-frame, rather than immediately after it is given to a patient .... Reuters
12/1 The Ins and Outs of Hubs
Why CVS Health and Express Scripts Sold — and McKesson Bought — a Specialty Hub Business .... CVS Health and Express Scripts divest businesses that could be perceived to conflict with their pharmacy benefit manager business. McKesson deepens its investment in non-wholesaling manufacturer services for specialty products .... Drug Channels
12/1 Opdivo Flushed Out Deep HIV Virus Reservoirs (Single Patient Observation)
Bristol-Myers Cancer Drug Opdivo Shows Surprising HIV Impact .... While the Paris patient's HIV DNA level never went down to zero, the results are promising since the normally stable measure dropped dramatically in 120 days, he said .... Bloomberg
12/1 PhRMA Says Drug Price Hikes Benefit PBMs and Payers, Not Manufacturers
Patients Don't Benefit From Drug Discounts To Insurers, PhRMA Report Says .... More than one-third of every branded pharmaceutical's list price is rebated back to health plans, government payers or other stakeholders. But at the same time, the out-of-pocket burden for deductibles rose 230% for people with employer-sponsored health insurance, while coinsurance payments grew 89% over the past 10 years .... Forbes/Arlene Weintraub
12/1 Sublocade Gets OK; Monthly Abdominal Buprenorphine Injection
FDA approves Indivior's monthly injection to treat opioid addiction .... Patients who get Sublocade will receive an abdominal injection administered by a health professional after starting a daily regimen of sublingual buprenorphine tablets for at least seven days .... Stat/MSN
12/1 FDA Hasn't Cut 75% of Regulations, Like the President Promised, But They Are Slowing Down a Few
Major Deregulation? FDA Withdraws Several Rules and Regulations Related to Medical Products .... Since January, the FDA has withdrawn the most rulemakings of any Department of Health and Human Services agency, though only a handful are related to medical products (the others are tobacco related) .... Regulatory Focus
12/1 Could be Record-Breaking Year for Drug Approvals — Here's What's Up in the Homestretch
9 Biotechs Facing FDA Decisions in December .... 40 drugs have been approved so far in 2017, with the record being in 2015, when 46 drugs were approved. Nine companies are awaiting decisions in December .... Biospace
12/1 Internet Drug News Fast Takes:
Foundation Medicine gets nod from FDA and Medicare for cancer test
Reuters
U.S. Government Should Negotiate Drug Prices, Adviser Group Says
Bloomberg
Kellyanne Conway to lead White House opioid effort
The Hill
Whistleblower says Medicaid managed-care firm improperly denied care to thousands of Californians
LA Times
Most Insurers Denying Claims for PCSK9 Inhibitors
Specialty Pharmacy Continuum
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11/30 OIG Pulls Support for Caring Voice Coalition, a Copay Assistance Charity
Pharma Charity May Shut After U.S. Faults Drugmakers' Influence .... [Caring Voice Coalition allegedly] provided drugmakers with data that could help them see if their contributions were helping their own customers, potentially giving the companies "greater ability to raise the prices of their drugs while insulating patients from the immediate out-of-pocket effects," and letting Medicare pay for the cost increases .... Bloomberg
11/30 Investigative Reporter Charges FDA is Burying AEs, Weak Evidence to Protect Sarepta
Is the FDA Withholding Data about a Controversial Drug to Protect Its Manufacturer? .... In the past several weeks, the agency has released thousands of pages of previously undisclosed documents about eteplirsen and its approval, and more are coming.... What's so striking in those documents is not the information that FDA is releasing, but the information that the agency refuses to release .... Scientific American
11/30 HHS Designate, Former Lilly Exec Says Current System of Pricing Insulin 'Not Working for Patients'
Health secretary nominee Azar says lowering drug prices a top priority .... Alex Azar, a former drug industry executive and lobbyist nominated to run the U.S. Department of Health and Human Services, has promised to lower drug prices and said he was unaware of any efforts to sabotage the healthcare law passed under former President Barack Obama .... Reuters
11/30 Helpful Chatbot Will Let You Know if You Have the Flu and What to Take for It
WebMD and Reckitt Benckiser launch new cold and flu chatbot .... The AI device provides an additional way for RB to gain actionable information on consumer behavior and it provides WebMD's users with a more interactive way of receiving credible, actionable and "snackable" health information. .... Drug Store News
11/30 High Stakes Fight Over 340B
Heated And Deep-Pocketed Battle Erupts Over 340B Drug Discount Program .... While the actual price of drugs will not be lower under the rule, Verma said beneficiaries will save an estimated $320 million a year on copayments. Medicare patients typically are responsible for a percentage of coinsurance on their prescriptions. The lowered Medicare reimbursement means that an enrollee's coinsurance would be lower at 340B hospitals because Medicare would pay hospitals less for the drug .... Kaiser Health News
11/30 Docs Will See Drug Costs, and Patients' Out-of-Pocket in New CVS System
CVS Health offers pharmacists, prescribers real-time benefit info for Caremark members .... The new real-time information offering will also offer prescribers better visibility of a drug's cost based on a patient's coverage, with the opportunity to review as many as five clinically appropriate branded alternatives or generics that are specific to a patient's formulary coverage .... Drug Store News
11/30 All You Need to Know About Pfizer, in 14 Parts
A Look at Pfizer's Key Drivers in 2017 .... Around 52% of the analysts tracking Pfizer in November 2017 recommended some form of a "buy" rating. On November 25, 2017, Pfizer had a consensus target price of $38.05, a 7.2% return on investment over the next 12 months .... Market Realist
11/30 NEJM Publishes Successful Trials of New Monthly Injections for Migraine
New, Long-Acting Drugs Cut Frequency of Migraine Headaches .... On erenumab, the number of days migraineurs suffered each month dropped by three to four in the drug groups and nearly two in the placebo group. Half of the patients on the higher dose saw their migraine days cut at least in half.... On fremanezumab, monthly headache days dropped by four to five in the groups given the drug and by two to three for those given dummy treatments .... AP/NY Times
11/30 $6 Billion in Debt Paid Off; $26 Billion to Go
Inside Valeant's Efforts to Be a Normal Drug Company .... Valeant doesn't owe debt until $4.4 billion comes due in 2020. Mr. Papa said the business's return to growth will come in part from new products like eye-surgery device Stellaris Elite, glaucoma drug Vyzulta and a psoriasis lotion in development could help reduce debt to a manageable level .... WSJ $$
11/30 Accomplished Athletes Who Are Also Cancer Survivors Get Campaign Spotlight
Merck drafts game plan for lung cancer with awareness campaign expansion .... Each focus area on the home website includes the starring spokesperson's story, but it also includes everyday patients and survivors in videos talking about their support systems, healthy eating and exercise, adjusting to a new normal with a cancer diagnosis, and more .... Fierce Pharma
Tweet of the Day
The price of insulin nearly doubled in the past four years.
— Sarah Kliff (@sarahkliff) November 29, 2017
Same exact drug.
Great data from @HealthCostInst pic.twitter.com/rcYEj2o87w
11/30 Internet Drug News Fast Takes:
Facebook explains advertising policies to its users but industry wants more
MM&M
Forecast predicts over half of U.S. children will be obese by age 35
Reuters
Cost of pneumococcal vaccine keeps rising
USA Today/Kaiser Health News
How working with Apple inspired Jeff Tangney to found Doximity
MM&M
HPV vaccine is effective, safe 10 years after it's given
Medical College of Georgia at Augusta University
11/29 Poor Long-Term Prospects for Pharma Business as It Gets Harder and More Expensive to Develop Effective Drugs
Pharma's broken business model: An industry on the brink of terminal decline .... Return on investment in pharma R&D is already below the cost of capital, and projected to hit zero within just 2 or 3 years. And this despite all efforts by the industry to fix R&D and reverse the trend .... Endpoints News
11/29 It's Not Like You Need a Doctor to Tell You When Need It: OTC Viagra Coming to UK
UK gives Pfizer world's first over-the-counter Viagra approval .... The drug will only be available in pharmacies and its supply will depend on pharmacists' assessment of its suitability for each individual .... Reuters
11/29 Ambitious Targets Mean More Misses — Immuno-oncology Drug Shows No Advantage
Brace for More Cancer-Drug Trial Failures .... Pfizer and partner Merck KGaA have announced that a clinical trial of their immune-boosting cancer drug Bavencio failed to help previously treated gastric-cancer patients survive longer than chemotherapy. But the firms had set a high bar for the drug to clear, hurting its chances .... Bloomberg Gadfly
11/29 Novo's CSO Views
Novo Nordisk CSO warns NASH market will develop slowly, urges all to 'moderate expectations' .... "We are still lacking the right way of diagnosing the disease - people have to take liver biopsies to make a diagnosis and most patients are not willing to do this because it's risky." (Mads Krogsgaard Thomsen, Novo Nordisk) .... Pharma Letter
11/29 Experts Complained Health Care was 'Silo-ed' and Fragmented. But Risks Abound as Partnering Spreads
As Health Care Changes, Insurers, Hospitals and Drugstores Team Up .... Tom Robinson, a partner for Oliver Wyman, estimates there have been about 200 partnerships created between insurers and large health groups in the last five years.... These partnerships can also represent a dramatic departure from the status quo .... NY Times
11/29 The Science Behind Heplisav-B
Ancient Bacterial DNA Could Thwart a Devastating Disease .... But unlike the two existing hepatitis B vaccines, the new vaccine also contains 3 milligrams of repeated linkages of cytosine and guanine — a molecular pattern unique to bacterial DNA called CpG oligonucleotides .... Daily Beast/Paul Offit
11/29 In 2Q 2017, One in Six ED Visits Was Opioid Related
How Opioids Started Killing Americans .... A huge study of the epidemic's acceleration shows most deaths began with a prescription .... Bloomberg (autoplay video)
11/29 Cigna Claims Integrated Medical/Pharmacy Benefit Saves $2,816 Per Diabetic Per Year
Cigna Customers with Connected Pharmacy and Medical Benefits Are More Active in Improving Their Health, Leading to Lower Medical Costs .... Employers with both pharmacy and medical benefits through Cigna experienced medical cost savings across all their plan members. Overall, employers saved an average of $74 per member per year on medical costs .... Cigna news release
11/29 Gottlieb Clarifies Drug + Device Generic Rules
FDA issues guidance that could make it easier for EpiPen rivals to come to market .... FDA issued guidance that says generic copies with some design differences may be approved as substitutable products.... This would be allowed as long as those differences don't hurt patients' ability to use the product the way it's intended .... CNBC
11/29 GSK Files Trelegy for COPD
As Advair struggles, GlaxoSmithKline seeks expanded label for blockbuster-to-be Trelegy .... Along with partner Innoviva, GSK has applied for approval for Trelegy as a maintenance treatment of airflow obstruction and to reduce exacerbations for patients with chronic obstructive pulmonary disease .... Fierce Pharma
11/29 Internet Drug News Fast Takes:
McCaskill Files Amendment to Eliminate Marketing Tax Deduction
Policy and Medicine
Health IQ raises $76 million to lower insurance rates for healthy people
Venture Beat
Tens of thousands dying from $30 billion fake drugs trade, WHO says
Reuters
OPDP Issues Third Warning of 2017
Regulatory Focus
AstraZeneca outlicenses Brilinta reversal agent
BioPharma Dive
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