The motion denied Amgen's bid for a temporary injunction that would have prevented the launch of Zarxio, the first FDA-approved biosimilar and a competitor to Amgen's Neupogen.
Kim Kardashian posts corrective information on Instagram and Twitter; DPP-4 inhibitors are linked to joint pain; doctors question off-label prescriptions of PCSK9 inhibitors
The FDA releases biosimilar-naming draft guidance; PD1 drugs linked to a rare type of diabetes; Amgen's PCSK9 inhibitor faces approval decision
US patent office declines to review two Ampyra patents; the FDA expands indication for Promacta; the Biosimilars Council argues against CMS proposal for biosimilar coding
The FDA encourages clinical testing of testosterone; Google spins out its life-sciences business; Novartis buys remaining rights to Arzerra
A new poll conducted by the Kaiser Family Foundation found that most Americans believe drugmakers should be required to release information to the public about how they set drug prices.
Could Kardashian West's now-notorious Diclegis social post be more than an OPDP case study?
State attorneys general accused the drugmaker of violating state consumer protection laws.
But don't expect the floodgates to open. Marketers still have to take a legal route to promote such information.
Court blocks generic competition for Opana ER until 2023; lawmakers question Valeant drug price hikes; Roche's immuno-oncology drug meets primary endpoint in mid-stage trial
The FDA pushed back Opdivo's PDUFA date in light of new data; lawmakers argue about vet co-pays; Merck and MD Anderson Cancer Center to evaluate Keytruda in stomach and liver cancers
The FDA said Kim Kardashian West's promotion of morning-sickness pill Diclegis misbranded the product by understating its risks.
"Me-too" drugs may help lower costs; start-ups send doctors to your home; the FDA is likely to appeal the Amarin ruling
The decision, a setback for the FDA, allows the drugmaker to move forward with plans to legally promote some off-label information.
Spritam is a prescription epilepsy adjunct delivered orally.
Sanofi plans immuno-oncology collaboration with Regeneron; Merck considers hard-to-treat patient populations for its experimental hepatitis-C therapy; drugmakers did not report 10% of adverse events to the FDA within required timeframe
A next-generation cardiovascular drug is expected to be approved this week, but concerns abound about who will take it—and how much it will cost.
Experimental Alzheimer's disease drugs produce mixed results; court rules in favor of Novartis in Zarxio case; Horizon Pharma increases its bid for Depomed
New rules will require manufacturers to report some indirect payments made to physicians for CME activities.
The FDA discusses working with Google to identify unknown drug side effects; Tavenner named chief of insurer lobby group; drugmakers are starting to use cultural experts to better understand patient experience.
Pharma's efforts to evolve restrictions about off-label marketing move forward.
The legislation would allow drugmakers to share information about their products beyond what is included on the FDA-approved label.
Pregnant women taking Prozac or Paxil have higher risks of birth defects; study finds J&J's experimental psoriasis drug works better than Humira; AstraZeneca divests global rights to Entocort
It's not always regulation or concerns about legal risks. Sometimes, a drugmaker's internal conservative culture is the biggest hurdle to overcome.
Los Angeles County voted in favor of adding the drug to the public health program's repertoire in fighting HIV and AIDS.
FDA panel recommends Sanofi/Regeneron's PCSK9 inhibitor for approval; Merck and Samsung collaboration says their rheumatoid arthritis biosimilars are equivalent to the biologic versions; Bayer offloads its diabetes-care business
Bristol-Myers Squibb's Opdivo serves up lukewarm lung-cancer results; new cancer drugs are too expensive, Sloan Kettering oncologist tells ASCO attendees; Teva settlement could stymie industry use of pay-for-delay patent tactics
An appeals court affirmed an earlier ruling that Actavis must keep an older formulation of its Alzheimer's drug, Namenda, on the market.
The legislation would allow drugmakers to share economic information with payers beyond what is included on the FDA-approved label.
FDA official says DTC risk claims are a waste of time; one analyst believes Afrezza could turn around sluggish sales; J&J inks billion-dollar deal to commercialize HCV drugs
- The MM&M Weekly News Quiz: September 4
- Five things for pharma marketers to know: Friday, September 4
- New data expected at lung-cancer conference on experimental drug combos
- Sandoz: Zarxio marketing to be similar to a branded-drug launch
- Five things for pharma marketers to know: Thursday, September 3, 2015
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