A Third Of Drug Development Costs Comes From Clinical Trials. Can Pharma Make Them Faster And Cheaper?

Bloomberg: Big Pharma’s Drug Studies Are Getting A NASA-Style Makeover 
Discoveries of new cancer-fighting and antiviral medicines grab headlines and sometimes win Nobel Prizes. But after the breakthroughs and backslapping are over, Big Pharma’s grunt work is just beginning. Companies carry out years of costly studies to prove treatments are safe and effective: finding hospitals and clinics to participate, hunting down patients who fit precise descriptions, tracking their health in minute detail for years while ensuring they take their medications, and then combing through heaps of data that will determine whether doctors can prescribe them. It’s the unsexy side of the industry, and it’s a big reason it can take more than $2 billion and 12 years to launch a new treatment. (Paton, 1/24)

Stat: Here’s How Massachusetts Officials Hope To Lower Medicaid Drug Spending
Once again, Massachusetts is trying to find a way to lower its Medicaid prescription drug bill, but this time, state officials hope to negotiate supplemental rebates — and potentially cite drug makers for violating consumer protection laws if they fail to play ball. The effort is the latest by state lawmakers to find a way to constrain drug spending, an issue that is stretching budgets across the U.S. amid rising prices, especially for some newer medicines. The move also comes after Massachusetts officials last year failed to win federal government approval to exclude some drugs from the state Medicaid program, which was an earlier attempt to reduce costs. (Silverman, 1/29)

Boston Globe: Drug Costs Plague Seniors, But Legislative Relief May Be Elusive
Lowering the cost of prescription drugs is a perennial issue in Congress and on Beacon Hill. But in the face of industry opposition and divided government, older Americans like Hogan — covered mainly by private Medicare drug plans — may have to wait until after the next election for relief. (Weisman, 1/28)

Stat: Drug Prices Forecast To Grow Slowly Over Next Five Years, But Some Will Feel Pain 
As debates over rising medicine costs escalate, a new analysis forecasts that the growth of prices in the U.S. for prescription drugs will range from 0 to 3 percent over the next five years. At the same time, drug makers will collectively register sales growth anywhere from 3 percent to 6 percent. By 2023, U.S. spending is expected to top $600 billion, up from nearly $500 million this year, although this is before factoring in the rebates and discounts that drug makers pay to pharmacy benefit managers to win favorable insurance coverage on lists of medicines called formularies. (Silverman, 1/29)

The Star Tribune: Tough Choices Over A Pricey But Effective Drug For Hepatitis C 
Hepatitis C is one of the most common infectious diseases, with the potential to cause serious liver damage, so patients were thrilled when a set of revolutionary new medications became available five years ago. But at $90,000 per treatment course, the drugs were pricey, and many states, including Minnesota, balked at covering them under their taxpayer-funded Medicaid programs. (Howatt, 1/28)

The Wall Street Journal: Pfizer Pivots To Cancer Drugs For Growth
Twenty years ago, Pfizer Inc. didn’t sell any drugs treating cancer. Now, it sells 17, including four that were approved in the U.S. at the end of last year, more than any other pharmaceutical company. The new lineup is projected to generate $8.3 billion in sales this year, according to EvaluatePharma. For the first time, Pfizer in 2019 expects oncology products to outsell the heart and other primary-care medicines the company was long known for. (Hopkins, 1/27)

Bloomberg: Pfizer’s Outlook Disappoints As Drugmaker Focuses On Pipeline
Pfizer Inc. issued a weaker financial forecast for 2019 than Wall Street expected, becoming the latest large drugmaker to warn about the ripple effects of a strong dollar. The pharmaceutical giant said it expects 2019 adjusted earnings per share of $2.82 to $2.92 — short of the average Wall Street analyst estimate of $3.04. Unfavorable foreign-exchange effects are expected to diminish sales by about $900 million this year, while cutting adjusted earnings per share by about 6 cents. (Griffin, 1/29)

The Wall Street Journal: Pfizer Results Hurt By Pricing Challenges
Pfizer Inc. said Tuesday its new medicines in development will increase sales, even though one of its biggest-selling drugs is expected to face generic competition this year. The New York-based drugmaker, the largest in the U.S. by revenue, said fourth-quarter sales increased 2% from a year earlier to $14 billion, slightly above analyst estimates. The company reported a loss of $394 million, or 7 cents a share, compared with a profit of $12.27 billion, or $2.02 a share, a year earlier, partly due to an impairment charge. Analysts polled by Refinitiv were expecting the company to earn 49 cents a share. (Hopkins and Chin, 1/29)

Asbury Park Press: Drug Prices: Can A Lakewood Company Save Independent Pharmacies?
To the 27-year-old Green, who was raised in the digital age, it looked out of place. And when the pharmacist told him what it was — sales offers from drug wholesalers — his mind started racing.”I said, ‘Hold on a second. We’re in the 21st century. Is there no simple way of really finding the cheapest price on all these drugs at once?'” Green said. Ezriel Green was standing in line at a Brooklyn pharmacy two years ago, trying to order a prescription, when he noticed a giant stack of papers on the counter. (Diamond, 1/29)

Reuters: Undeterred By Sanofi’s Stumble, Takeda Takes Similar Path With Dengue Shot
A new vaccine for the dengue virus is taking a potentially risky road to prevent the mosquito-borne disease that infects nearly 400 million people each year. Takeda Pharmaceutical Co Ltd plans to seek approval for the experimental vaccine first in countries where the virus is endemic, rather than starting with the United States or Europe, whose rigorous reviews are often used as a benchmark worldwide, company executives told Reuters. (Steenhuysen, 1/30)

Reuters: Botox Maker Allergan’s Revenue Forecast Misses Estimates, Shares Drop
Allergan Plc on Tuesday forecast 2019 revenue below expectations on looming competition for some of its top drugs, and shelved plans to sell its women’s health business.The Botox maker’s shares fell 6 percent to $149.20 in early trading. (Mishra, 1/29)

Stat: CEO Emma Walmsley Takes GlaxoSmithKline On A Quest For Identity
Emma Walmsley became the chief executive of GlaxoSmithKline 22 months ago, looking like the opposite of a pharma insider: She was, instead, steeped in the business of selling toothpaste and Tums. Appearances may have been deceiving — because she’s betting on drugs. Walmsley had run Glaxo’s consumer business for five years, and had previously worked for 17 years at L’Oréal. But if her tenure at the helm of Glaxo so far makes one thing clear, it’s that she is now all-in on pharma. In three years she plans to spin off the same consumer business she ran after merging it with Pfizer’s unit that sells Listerine and ChapStick, and, by the way, larding the new company with accumulated debt she’s sure it can quickly pay off. (Herper and Silverman, 1/28)

The Wall Street Journal: Novartis Seeks Growth In Newer Drugs Amid Pricing Challenges
Novartis AG is counting on strong sales of its newer medicines to offset mounting pressure on drug prices this year. The Swiss health-care giant said Wednesday it expected sales to grow by a mid-single-digit percentage in 2019, even though it is likely to have to cut the prices of its drugs. Chief Executive Vas Narasimhan said on a call with reporters that he expected Novartis’s net prices to decline by a low-single-digit percentage this year. (Roland and Mancini, 1/30)

Stat: How Realistic Is An ‘Off-The-Shelf’ CAR-T Drug? 
It’s the ultimate example of personalized medicine — for some cancer patients who have run out of options, scientists can extract their immune cells and genetically re-engineer them to fight against the tumors. But there are only two companies in the U.S. approved to make these medicines, known as CAR-T therapies, and it costs both money and time — the therapies list for $373,000 and $475,000 and take two to three weeks to produce for each patient. (Swetlitz, 1/30)

Stat: Lyndra Therapeutics Raises $55 Million From Gilead And Gates 
Lyndra Therapeutics just raised $55 million from big-name investors like Gilead Sciences and the Bill and Melinda Gates Foundation — both of which have strong connections to HIV research and drug development. But the company, which is developing once-a-week pills for a variety of diseases, cautions that HIV drugs aren’t necessarily next on its list. (Sheridan, 1/29)