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Chinese hackers linked to the mainland government attempted to gain entry into computer systems at 7 companies including two unnamed pharmaceutical companies, according to a U.S. cybersecurity researcher…the attacks began on Sept. 26, but were ultimately unsuccessful. News of the attacks came a day after President Barack Obama and Chinese President Xi Jinping had agreed to stop any government attempts to penetrate corporate networks to support their respective domestic industries… Pharmaceutical companies are a natural target for hackers looking to help their clients or employers shave years and billions of dollars off the time and expense of creating modern drugs.

An advisor to the pharma industry on M&A says the current boom in pharma valuations will not last, and R&D cost pressures will reshape firms of the future… transaction sizes of mergers and acquisitions in pharma have hit an all-time high: "You don’t see these revenue multiples in any other industry."…After the bubble bursts: what’s next for pharma?... in response to pressure from governments to lower their healthcare spending…R&D will become prohibitively expensive for medium-sized players, leading companies to reshape themselves according to four strategic archetypes:

1. Originators
2. Generics and biosimilar makers
3. Point-of-call specialists
4. Over-the-counter companies

..Imprimis says it will offer a compounded drug that includes Daraprim's active ingredient--pyrimethamine--in capsules starting at $99 for a 100-count bottle. The company is also starting a program to work with payers, pharmacy benefits managers and purchasing groups to offer patient-specific formulations "at prices that ensure accessibility."…The compounded drug isn't an exact copy; it also includes the ingredient leucovorin, which…helps to combat pyrimethamine's negative effects on bone marrow…After the meningitis outbreak linked to the New England Compounding Center, new regulations tightened up on distribution of compounded drugs, which aren't specifically approved by the FDA. Compounded meds can only be dispensed on specific prescriptions for specific patients, rather than distributed in bulk as FDA-approved products are...

Tricare officials say the problem stems from drug shortages…shortages are exacerbated within the military system because by law, DoD is allowed to buy pharmaceuticals only from certain manufacturers… shortages peaked at about the time DoD began requiring Medicare-eligible retirees and military family members to fill their long-term prescriptions by mail or at a military pharmacy…GAO Health Care Director Debra Draper pointed out that, since Tricare did not specifically track the satisfaction of beneficiaries now required to use the mail-order system and did not monitor the availability of covered medications for these beneficiaries, DoD is "unable to assess availability."…"DoD does not know what, if any problems, beneficiaries may have experienced filling their prescriptions,"…

Brian Haug, President of Pharmacy and Managed Markets, Pharmacy Times (PTNN) This weekly video program highlights the latest in pharmacy news, product news, and more. (video)

Enforcement officers from the Medicines and Healthcare products Regulatory Agency have seized approximately half a million doses of unlicensed erectile dysfunction medicines, with an estimated value of more than £1 million ($1.5m), during a raid on in Datchet, Slough...A 37 year old man has been arrested… The news comes less than two months after Sundeep Amin from Essex was sentenced to 16 months in prison after MHRA officers seized £900,000 worth of falsified ED drugs en route from India..

…complaints might be dismissed as growing pains, born of resistance to change. But transitional chaos must be distinguished from enduring harm…the EHR's limitations and why they've been largely ignored, one key barrier is that physicians who voice reservations are labeled "technophobic, resistant, and uncooperative." But in fact…most physicians recognize the potential of EHRs and appreciate such features as the ability to view data remotely. Nevertheless, the researchers found remarkable EHR-induced distress. They conclude, "No other industry, to our knowledge, has been under a universal mandate to adopt a new technology before its effects are fully understood, and before the technology has reached a level of usability that is acceptable to its core users."...What this surgeon and the rest of us need are patient records that communicate meaning and foster understanding of the particular patient in question. The blanks on our screens can be filled with words, but the process of understanding cannot be auto-populated. Perhaps life without the EHR will soon be unimaginable. But the technology will support and improve medical care only if it evolves in ways that help, rather than hinder, us in synthesizing, analyzing, thinking critically, and telling the stories of our patients.

..first-in-class drug from Amgen based on a tumour-killing virus was given a green light by European regulators…paving the way for its approval within a couple of months…The decision is a further milestone for a technology that has long fascinated scientists but has previously proved difficult to harness…The European Medicines Agency said its experts had recommended approval of Imlygic, also known as talimogene laherparepvec or "T-Vec", for treating melanoma, making it another option among several new drugs for the most deadly form of skin cancer. Imlygic uses a herpes simplex virus...which has been modified to only infect cancer cells. It is injected directly into tumours where it replicates and causes cancer cells to rupture and die, also stimulating a system-wide immune response.

Valeant Pharmaceuticals rout put specialty pharmacies under an unwelcome spotlight. But though Valeant's own close relationship with Philidor RX may be an unusual one--a host of Big Pharma and Big Biotech companies have now denied similar arrangements--tight links between drug marketing and specialty pharmacies are increasingly common industry wide…Valeant is hardly alone in depending on a specialty pharmacy for sales success. What began as a technique for getting "complex, costly drugs"--often orphan meds for rare diseases--to the appropriate patients has become a broadly used marketing technique…Pharma's pricing and marketing moves are going to stay on center stage for some time.

In their Perspective article…Avorn and Kesselheim argue that the 21st Century Cures Act, which is currently being debated in Congress, would lower the regulatory standards of the Food and Drug Administration by giving it greater discretion to approve drugs on the basis of less rigorous data…the legislation would authorize the FDA to "rely" on observational analyses, which are less rigorous than randomized controlled trials. But the Cures Act does not diminish the FDA's standards for requiring that new medical products are safe and effective. Rather, it recognizes that recent developments in genomics, systems biology, electronic data systems, and other fields can provide additional tools and resources to support better premarketing and postmarketing regulation and more efficient development of drugs and medical devices…Better evidence and up-to-date regulatory science are the best foundation for regulatory decisions and meaningful progress in biomedical innovation. They are also the best way to avoid turning back the clock on new opportunities to develop safe and effective treatments for unmet medical needs...