Drug Approvals at 19-year High Belie Industry Challenges - Rawan For Media Artistic and Production
Across the Atlantic, the European Medicines Agency recommended 93 new products, including generics, up from 82 in 2014.
But
despite the rosy statistics and the prospect for further progress in
2016, the pharmaceuticals industry faces challenges, with increased
political focus on drug pricing having punctured both biotech and
specialty pharma valuations in recent months.
The
prospect of Hillary Clinton becoming U.S. president could further
undermine confidence in the sector's profitability in 2016, given her
pledge to rein in drug costs. But any changes in the U.S.
Big
pharmaceutical companies, meanwhile, are still struggling to get a
decent return on the billions of dollars spent annually on research and
development, since many new medicines are forecast to yield relatively
modest sales.
Moreover,
securing a strong launch for new drugs, which must compete with a
growing roster of cheap generics, is often an uphill battle as
healthcare providers push back against the high prices being charged.
Modern cancer drugs can cost more than $10,000 a month, placing a heavy financial burden on governments, insurers and patients.
The
rapid pace of new approvals reflects accelerated review times by
regulators, who want to get life-saving treatments to patients,
especially in cancer, as well as an improved scientific understanding of
diseases.
That
will continue in 2016, analysts believe, with further advances in
cancer treatments that work by boosting the immune system, and
significant progress in drugs for autoimmune diseases.
Switzerland's
Roche, the world's largest cancer drug company, could be a notable
winner on both counts, with its cancer immunotherapy atezolizumab on
track for potential fast approval in 2016.
Roche
may also be the first company with a drug to treat the progressive form
of multiple sclerosis and some analysts already forecast annual sales
for ocrelizumab of $5 billion.
Plenty
of other companies also have promising new products waiting in the
wings for a variety of cancers, as well as disorders including
psoriasis, rheumatoid arthritis, hepatitis C and chronic lung disease.
Full drug pipelines at many companies suggest the strong rate of new drug launches is likely to continue for a while yet, with
By Reuters, 13 hours 48 minutes ago
2015
was a good year for innovation in medicine with the U.S. Food and Drug
Administration approving 45 novel drugs, four more than in 2014 and the
most since the all-time record of 53 set in 1996.
was a good year for innovation in medicine with the U.S. Food and Drug
Administration approving 45 novel drugs, four more than in 2014 and the
most since the all-time record of 53 set in 1996.
Across the Atlantic, the European Medicines Agency recommended 93 new products, including generics, up from 82 in 2014.
But
despite the rosy statistics and the prospect for further progress in
2016, the pharmaceuticals industry faces challenges, with increased
political focus on drug pricing having punctured both biotech and
specialty pharma valuations in recent months.
The
prospect of Hillary Clinton becoming U.S. president could further
undermine confidence in the sector's profitability in 2016, given her
pledge to rein in drug costs. But any changes in the U.S.
pricing model are likely to be gradual, according to Bernstein analyst Tim Anderson.
Big
pharmaceutical companies, meanwhile, are still struggling to get a
decent return on the billions of dollars spent annually on research and
development, since many new medicines are forecast to yield relatively
modest sales.
Moreover,
securing a strong launch for new drugs, which must compete with a
growing roster of cheap generics, is often an uphill battle as
healthcare providers push back against the high prices being charged.
Modern cancer drugs can cost more than $10,000 a month, placing a heavy financial burden on governments, insurers and patients.
The
rapid pace of new approvals reflects accelerated review times by
regulators, who want to get life-saving treatments to patients,
especially in cancer, as well as an improved scientific understanding of
diseases.
That
will continue in 2016, analysts believe, with further advances in
cancer treatments that work by boosting the immune system, and
significant progress in drugs for autoimmune diseases.
Switzerland's
Roche, the world's largest cancer drug company, could be a notable
winner on both counts, with its cancer immunotherapy atezolizumab on
track for potential fast approval in 2016.
Roche
may also be the first company with a drug to treat the progressive form
of multiple sclerosis and some analysts already forecast annual sales
for ocrelizumab of $5 billion.
Plenty
of other companies also have promising new products waiting in the
wings for a variety of cancers, as well as disorders including
psoriasis, rheumatoid arthritis, hepatitis C and chronic lung disease.
Full drug pipelines at many companies suggest the strong rate of new drug launches is likely to continue for a while yet, with
By Reuters, 13 hours 48 minutes ago
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