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The specialty drugs market is seeing increased competition and important advances in cancer and orphan drug development, including specialty generics and biosimilars...Following December’s FDA approvals of the intravenous biosimilar Lartuvo (olaratumab) for soft tissue sarcomas and the oral ovarian cancer biosimilar Rubraca (rucaparib), biosimilar and other specialty drug approvals are expected to hasten in 2017... Last year we saw a dip in...approvals but this year we are going to rebound with about 30 pending approvals...With 73 patent expirations for biologic agents by 2021, biosimilars will begin to emerge as a larger market presence in the next several years...New FDA biosimilars approvals over the next five years—including anticipated biosimilar approvals for the anti-cancer biologic agents Avastin (bevacizumab) and Herceptin (trastuzumab)—could represent a $46.2 billion market...Biologics are really acting more like competing brands, coming in at perhaps a 15% discount" compared to brand-name biologics...

• Pending approvals/patent expirations
• Recently approved specialty medications
• Specialty drug pipeline

Opioid makers have had no shortage of critics in recent years as the United States suffers the sting of a painful addiction epidemic. Now, a top senate Democrat is throwing the weight of her office behind efforts to dig into the industry’s marketing practices for the risky painkillers...Sen. Claire McCaskill is targeting Johnson & Johnson, Mylan, Depomed, Insys and Purdue in her investigation, which is aimed at learning whether the companies had any role in the country’s "overutilization and overprescription" of the meds...Among the documents she’s requesting are internal opioid abuse estimates, info on marketing strategies, sales quotas and contributions to patient groups...McCaskill laid out evidence that suggests drug companies sought to downplay the risks of the painkillers and positively influence physicians’ perceptions of the meds. She wrote that the allegations "show an industry apparently focused not on preventing abuse but on fostering addiction as a central component of its business model."

...Johnson & Johnson has halted all global advertising on the video-sharing site YouTube in response to concerns product marketing appeared next to offensive content such as hate speech…J&J joins a growing list of large corporations, including major advertiser AT&T, that have opted to pull advertising from running on the Google-owned media channel...Alarm began to spread following an investigation by the British newspaper The Times which found advertising from well-known brands appeared next to content from extremist groups. ISBA, a U.K. advertising association with over 400 corporate members, urged Google shortly thereafter to review its policies and withdraw any ad inventory it could not guarantee wouldn't appear next to offending material

Biogen's defense of its blockbuster multiple sclerosis treatment Tecfidera (dimethyl fumarate) got a lift...after the U.S. Patent Trial and Appeal Board rejected a patent challenge by a group affiliated with hedge fund manager Kyle Bass...The...Board upheld Biogen's '514 patent on the 480 mg dose of Tecfidera, boosting the chances Biogen will be able to maintain patent protection on the top-selling drug for longer...Despite the positive development, Biogen hasn't fully put to rest the patent challenges surrounding Tecfidera. So-called interference proceedings between the company and Forward Pharma are still ongoing at the Patent Trial and Appeal Board, which could force Biogen to pay Forward royalties on sales of Tecfidera.

The Ohio governor unveiled a plan...that targets the place where experts say many opioid addictions begin — the doctor's office...Gov. John Kasich's order limits the amount of opiates primary care physicians and dentists can prescribe to no more than seven days for adults and five days for minors...In addition to the pill limits, Kasich said the new rules require doctors to provide a specific diagnosis and procedure code for every painkiller prescription they write...And Kasich warned that doctors who don't follow the rules will lose their licenses...The new limits, which have gotten the blessing of the Ohio Board of Pharmacy, the State Medical Board, and the state's dental and nursing boards, do not apply to patients who take prescription painkillers for cancer treatment or to dying patients who are already receiving hospice care...As bad as things are in Ohio, it's ever worse in West Virginia, New Hampshire and Kentucky, which have even higher drug overdose death rates, according to the federal Centers for Disease Control and Prevention...Americans get hooked on locally prescribed painkillers, lawmakers say the drug cartels have made a mint feeding their habits by smuggling Chinese-made fentanyl and other opioids into the country

Europe's medicines regulator has recommended the suspension of more than 300 generic drug approvals and drug applications due to "unreliable" tests conducted by Indian contract research firm Micro Therapeutic Research Labs...The decision, announced by the European Medicines Agency...is the latest blow for India's drug-testing industry, which has run into a series of problems with international regulators in recent years...The inspections identified several concerns at the company’s sites regarding misrepresentation of study data and deficiencies in documentation and data handling...there is no evidence of harm or lack of effectiveness of the medicines, which include generic versions of many common prescription pharmaceuticals, including blood pressure tablets and painkillers...Drug tests carried out at Indian contract research organizations have been key in getting a huge array of generic medicines approved for sale around the world over many years…In the wake of such trial data scandals, many large drugmakers have been shifting more critical trials back to the United States and Europe over the last three years...

HHS again has delayed enforcement of a final rule that would penalize drugmakers that deliberately overcharge providers for drugs purchased under the 340B drug discount program...The federal 340B program requires drug manufacturers to provide outpatient drugs to eligible health care providers at discounts ranging from 20 to 50 percent...the program has come under scrutiny, with some questioning the amount of charity care participating hospitals are providing...Under the final rule...drugmakers that "knowingly and intentionally" overcharge providers for drugs purchased through the program will face a fine of up to $5,000 per offense. The drugmakers also have to repay the overcharge...The rule took effect on Feb. 28 and was scheduled to be enforced beginning April 1...HHS again delays enforcement date...HHS in an interim rule published Monday in the Federal Register again delayed the rule's enforcement date, this time to May 22.

"From research to health care: Your pharmacist is at your service" is the theme of this year’s World Pharmacists Day on 25 September, the International Pharmaceutical Federation (FIP) announced..."This theme was chosen to reflect the numerous contributions the pharmacy profession makes to health. From research and development of medicines, to educating future pharmacists and pharmaceutical scientists, and providing direct care, we do all this in the service of our patients and communities," said FIP President Dr Carmen Peña..."We want to emphasise that pharmacists are the backbone of health care in many different settings. But providing care does not begin in community or hospital pharmacies. Taking care of patients starts with recognising the health issues of populations and developing medicines, policies and education to tackle them. We pharmacists are often there at the very beginning of the process — when the first molecule that effectively treats a disease is identified," Dr Peña added...World Pharmacists Day is used by FIP’s members and others around the globe to highlight the value of the pharmacy profession and impact on improving health to authorities, other professions and the media, as well as to the general public...FIP is inviting pharmacists to support World Pharmacists Day by creating profile pictures for their social media accounts using the official FIP Twibbon or a specially designed "Your pharmacist is at your service" placard. The materials are available from today at www.fip.org/worldpharmacistsday.

Pharmacy benefit managers and tech startups are responding to underinsurance and the onslaught of high-deductible health plans by cutting out insurers in the quest to help patients lower their prescription drug costs...Two PBMs have launched discount programs for patients to use outside of any insurance coverage they might have. It's a notable contrast to PBMs' main business serving as third-party administrators of prescription drug coverage for insurers and employers...These efforts come as a budding industry has sprung up around helping consumers and employers rein in prescription drug costs. Startups like Blink Health and RefillWise offer pharmacy cards that provide consumers with negotiated discounts if they don't use their prescription coverage, while some insurers and pharmacy benefit managers, along with tech firm Castlight Health, are attempting to allay consumer and employers' concerns about drug costs by building apps that offer price transparency to physicians or patients.

For years, the FDA’s adverse events system has been derided because of its largely voluntary nature — only drug companies, not doctors or patients, are required to report problems. As a result, the system likely only was capturing a small percentage of cases...In recent years, the number of reports filed has been multiplying, prompting more independent researchers and drug companies to use the data as a way to detect safety problems...The surge in reports could indicate a growing number of harmed patients or more vigilant reporting of adverse events, a goal of the FDA. Experts say both likely play a role...Twelve years ago, there were 206,000 reports of side effects from medications filed with the FDA — complaints as frivolous as flatulence, as serious as death...By 2015, the most recent full year of data, the number had grown to 1.2 million...